N/A 309701Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 30382903097013), received between Oct 23, 2017 and Jan 8, 2025 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (17 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD SYRINGE 1ML ST BULK CONVENIENCE PAK LABEL CONTENT INCORRECT. IT WAS REPORTED BY CUSTOMER THAT THE DIFFERENCES BETWEEN THE LABELING ON THE BOX VS. THE LABELING ON THE OUTSIDE OF THE TRAY PACKAGING VS. THE LOT AND EXPIRATION DATE ON THE COC. RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER IS HAVING ISSUES WITH THE DIFFERENCES BETWEEN THE LABELING ON THE BOX VS. THE LABELING ON THE OUTSIDE OF THE TRAY PACKAGING VS. THE LOT AND EXPIRATION DATE ON THE COC. CAN YOU PLEASE CORRECT THE COC TO REFLECT THE LOT NUMBER AND EXPIRATION DATE 11/30/2028 AND SEND IT BACK TO ME? CUSTOMER CANNOT USE THIS PRODUCT DUE TO THE DISCREPANCY. THIS IS A MEDICAL DEVICE AND ALL THE INFORMATION MUST MATCH. PLEASE ADVISE IF YOU CAN UPDATE THE COC. THANKS. PRODUCT NUMBER - 309701. LOT NUMBER - 4149225.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102759 ↗
• MalfunctionMay 15, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD SYRINGE 1ML ST BULK CONVENIENCE PAK HAD SCALE MARKING ISSUE IT WAS REPORTED BY CUSTOMER THAT ILLEGIBLE MARKINGS ON THE BARREL, RENDERING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED MY TEAM REPORTED THAT THE BD 1ML SLIP TIP SYRINGE REF (B)(4) HAD ILLEGIBLE MARKINGS ON THE BARREL, RENDERING IT UNSAFE TO USE. THE SYRINGE HAS NOT BEEN WIPED WITH ANY SOLVENT, IT CAME OUT OF THE PACKAGE AS SHOWN. THE SYRINGE WAS NOT USED, NO PATIENTS HAVE BEEN INVOLVED IN AN INCIDENT WITH THESE SYRINGES. IT WAS REPORTED PRIOR TO USE. PLEASE SEE PHOTOS ATTACHED. BEST REGARDS, (B)(6) BSCH, BSCPHM COORDINATOR, PHARMACY SERVICES - ST. JOSEPH'S HOSPITAL TEL: (B)(6) (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321079 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 1ML ST BULK CONVENIENCE PAK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS." WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF # PC (B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: ________________________________________ PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 309701 PRODUCT DESCRIPTION: SYRINGE HYPO 1CC L/S CONV PACK && BULK STER BX/25 LOT/SERIAL #: (B)(6) EXPIRY DATE: 2027-10-31 PROBLEM INFORMATION WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS. OCCURRENCES: RECURRING REPORTER INFORMATION REPORTER NAME: XXXXXX REPORTER POSITION/DEPARTMENT: MATERIAL MGMT REPORTER PHONE: XXXXX REPORTER EMAIL: [email protected] SITE INFORMATION XXXXXX SAMPLE INFORMATION INCIDENT SAMPLES: YES -PENDING QTY REPRESENTATIVE SAMPLES: YES- PENDING QTY NO ADVERSE EVENT REPORTED ------------------------------------------- PLEASE FIND ATTACHED PRODUCT COMPLAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996867 ↗
• MalfunctionMar 26, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 1ML ST BULK CONVENIENCE PAK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS. VERBATIM: WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF#(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: ________________________________________ PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 309701 PRODUCT DESCRIPTION: SYRINGE HYPO 1CC L/S CONV PACK && BULK STER BX/25 LOT/SERIAL #: (B)(6). EXPIRY DATE: 2027-10-31 PROBLEM INFORMATION WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS. OCCURRENCES: RECURRING REPORTER INFORMATION REPORTER NAME: XXXX REPORTER POSITION/DEPARTMENT: MATERIAL MGMT REPORTER PHONE: XXXX REPORTER EMAIL: (B)(6). SITE INFORMATION XXXXX SAMPLE INFORMATION INCIDENT SAMPLES: YES -PENDING QTY REPRESENTATIVE SAMPLES: YES- PENDING QTY NO ADVERSE EVENT REPORTED ------------------------------------- PLEASE FIND AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981950 ↗
• MalfunctionFeb 14, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705377 ↗
• MalfunctionFeb 13, 2024Defective Device; Defective Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698250 ↗
• MalfunctionJun 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A HOLE IN THE PAPER PACKAGING OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY LEFT THE PRODUCT UNSTERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PACKAGE OF 1ML SYRINGES ARRIVED WITH A HOLE IN THE PAPER COVER OF THE TRAY. THE PRODUCT IS NO LONGER STERILE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14835642 ↗
• MalfunctionDec 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AT LEAST ONE BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK EXPERIENCED A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DISCOVERED BD 1ML SYRINGES WHICH WERE NOT-STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082355 ↗
• MalfunctionJul 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 1ML ST BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT AN ANIMAL HAIR WAS FOUND INSIDE THE TRAY SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168104 ↗
• MalfunctionJun 22, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT SYRINGE 1ML ST BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS A BLACK POWDER LIKE SUBSTANCE IN A SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040516 ↗
• MalfunctionDec 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 25 BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAKS EXPERIENCED MOLDING DEFECTS -SHORT SHOTS ON BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309701 BATCH NO: 0092223 I'M REACHING OUT IN REGARDS TO WHAT APPEARS TO BE A MOLDING ISSUE WITH OUR 1ML SLIP TIP SYRINGE'S. THIS PARTICULAR ISSUE IS FOUND IN THE 25 COUNT TRAYS THAT WE ORDER. THE DEFECT APPEARS TO BE A SMALL INDENTATION AND IS ABOUT 0.5 CM IN LENGTH, IT IS THE SAME SIZE AND SHAPE ON EVERY AFFECTED SYRINGE THAT WE ENCOUNTER LEADING US TO BELIEVE IT COULD BE AN ERROR WITH THE MOLDING.

  Patient problems: No Patient Involvement

  MAUDE report 10962197 ↗
• MalfunctionNov 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 1ML ST BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309701; BATCH NO: 0007599. IT WAS REPORTED THAT THE SYRINGE WAS DIRTY (ACCORDING TO GOOGLE TRANSLATION). EVENT DESCRIPTION PER EMAIL STATES: WHEN OPENING THE SYRINGE TRAY 1 ML 1 OF THE SYRINGES WAS "DIRTY" AND THEREFORE CONTAMINATED. SAMPLE NOT AVAILABLE (ACCORDING TO GOOGLE TRANSLATION).

  Patient problems: No Patient Involvement

  MAUDE report 10908826 ↗
• MalfunctionDec 26, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 8 BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAYS WERE FOUND WITH "ILLEGIBLE" SCALE MARKINGS AND FOREIGN MATTER IN THEM BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARTICULATE FOUND ON THE INSIDE AS WELL AS ILLEGIBLE GRADUATION MARKS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521191 ↗
• MalfunctionNov 22, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED IN STERILE SYRINGE TRAY WITH A BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND IN ONE OF THE CUSTOMERS STERILE SYRINGES TRAYS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365489 ↗
• MalfunctionAug 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT HAS BEEN REPORTED THAT THE SYRINGE 1ML ST BULK CONVENIENCE PAK HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PARTICLES/MARKS WERE FOUND INSIDE THE SYRINGES. EVENT DESCRIPTION STATES, "COMPLAINT : THE SYRINGES HAD SOME PARTICLES/MARKINGS INSIDE OF THEM."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927941 ↗
• MalfunctionAug 15, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML ST BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309701 BATCH NO. 8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543. PER EMAIL: WE NEED TO RETURN ALL THESE SYRINGES FROM BD, AS THEY HAVE A STRANGE WHITE RESIDUE WITHIN THE TOP OF EVERY SYRINGE. BD 1ML SYRINGE SLIP TIP CONV TRAY LOT # 8338895, 9003600, 9037699, 9037716, 9037717, 9091734 AND 9127543.

  Patient problems: No Patient Involvement

  MAUDE report 8899499 ↗
• MalfunctionJul 2, 2019Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  MATERIAL NO. 309701, BATCH NO. 8256581. IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY THERE WERE ELEVEN ISSUES. SIX WERE FOUND WITH DIFFERENT TYPES OF FOREIGN MATTER CONTAMINANTS, FOUR HAD MISSING PLUNGERS, AND ONE WAS FOUND WITH A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM THE QUALITY ASSURANCE SPECIALIST WE HAVE DISCOVERED ELEVEN ISSUES FROM THE LAST SIX MONTHS OF THIS YEAR. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS. FOUR EMPTY 1ML BD SYRINGE -SLIP TIP IN TRAY WERE FOUND WITHOUT PLUNGERS IN THE SYRINGES BARREL. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH A GRADUATED MARKING DEFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8755788 ↗
• MalfunctionJul 2, 2019Leak/Splash; Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Leak/Splash; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 9000 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS FROM LOT # 9037716 HAD SCALE MARKINGS THAT WERE INCOMPLETE, BLURRY, AND/OR WERE NOT LEVEL AROUND THE BARREL, AND AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH "CLOUDY" FOREIGN MATTER IN THEM. 16500 TRAYS FROM LOT # 9037717 WERE FOUND WITH DEFECTIVE HUBS/STOPPERS, WHILE AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH FOREIGN MATTER IN THEM. 13200 TRAYS FROM LOT # 9091734 WERE ALSO FOUND WITH FOREIGN MATTER IN THEM, AS WERE AN UNKNOWN NUMBER OF TRAYS FROM LOT # 9037699. ALL DEFECTS FROM ALL LOTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPS VISUAL INSPECTORS HAVE BEEN DETECTING FREQUENT DEFECTS WITH THE 1ML BD SLIPTIP SYRINGES. THE GRADUATION MARKINGS PRINTED ON THE SYRINGES ARE EITHER INCOMPLETE, BLURRY, AND/OR TWISTED AROUND THE SYRINGE BARREL CAUSING INACCURATE READING OF THE FILL VOLUME. FURTHER, UPON CLOSER INSPECTION, OTHER DEFECTS HAVE BEEN IDENTIFIED AMONG THE REMAINING INVENTORY LOT# AS WELL (IE. CLOUDY SUBSTANCE INSIDE SYRINGE HUB, SEVERE ABRASION ON HUB, DEFECTIVE/INCOMPLETE SYRINGE PLUNGER).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8753740 ↗
• MalfunctionJun 26, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH SYRINGES 1ML ST BULK CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, MATERIAL NO. 309701, BATCH NO. 8274580. IT WAS REPORTED THAT THERE WAS ISSUES WITH THE 1 ML BD SYRINGES SLIP TIP TRAY. SIX WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS, FOUR HAD MISSING PLUNGERS, AND ONE WAS FOUND WITH A SCALE MARKING ISSUE. PER RESPONSE EMAIL: A FOREIGN BROWNISH SPOT WAS SEEN AROUND THE TIP OF 1ML SYRINGE. THIS WAS NOTICED UPON OPENING THE SYRINGE TRAY PRIOR TO USING FOR FILLING PER EMAIL: I AM THE QUALITY ASSURANCE SPECIALIST . WE HAVE DISCOVERED FOURTEEN ISSUES FROM THE LAST SIX MONTHS OF THIS YEAR. PLEASE ACCEPT THIS EMAIL AS MY OFFICIAL NOTIFICATION OF OUR OBSERVATIONS AND I AM REQUESTING BD TO CONDUCT AN INVESTIGATION AND IF APPLICABLE IMPLEMENT A CAPA INTO THE OBSERVATIONS. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS FOUR EMPTY 1ML BD SYRINGE -SLIP TIP IN TRAY WERE FOUND WITHOUT PLUNGERS IN THE SYRINGES BARREL. ONE EMPTY 3ML BD SYRINGE -LUER LOCK IN TRAY WAS FOUND WITH SOME TYPE OF CONTAMINANT. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735769 ↗
• MalfunctionJun 25, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BEFORE USE SCALE MARKING ISSUES WERE DISCOVERED WITH A BD SYRINGE 1ML ST BULK CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:. MATERIAL NO. 309701, BATCH NO. 8274580. (2OF2). IT WAS REPORTED THAT THERE AN ISSUE WITH THE 1 ML BD SYRINGES SLIP TIP TRAY. A SCALE MARKING ISSUE. PER RESPONSE INITIAL REPORTERS EMAIL: ILLEGIBLE GRADUATED MARKINGS WERE NOTICED ON 1ML BD SYRINGE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732585 ↗
• MalfunctionJun 25, 2019Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATTER AS WELL AS SCALE MARKING ISSUES WITH A BD SYRINGE 1ML ST BULK CONVENIENCE PAK, THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309701, BATCH NO. 8274580. (2 OF 2). IT WAS REPORTED THAT THERE WAS ISSUES WITH THE 1 ML BD SYRINGES SLIP TIP TRAY. SIX WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS, AND ONE WAS FOUND WITH A SCALE MARKING ISSUE. ADDITIONAL INFORMATION PROVIDED BY REPORTER: A BROWNISH FOREIGN MATTER (DIRT) NOTICED ON THE PLUNGER OF 1ML SYRINGE. THIS WAS DETECTED UPON OPENING THE TRAY PRIOR TO USING FOR FILLING. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH A GRADUATED MARKING DEFECT. -PLEASE NOTE THAT ALL OF THE ISSUES WERE DETECTED PRIOR TO FILLING PRODUCTS INTO THEM SO NO PATIENT SAFETY WAS AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732277 ↗
• MalfunctionJun 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309701, BATCH NO. 8274580. IT WAS REPORTED THAT THERE WAS ISSUES WITH THE 1 ML BD SYRINGES SLIP TIP TRAY. SIX WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS, FOUR HAD MISSING PLUNGERS, AND ONE WAS FOUND WITH A SCALE MARKING ISSUE. PER RESPONSE EMAIL: ONE DIRTY LOOKING SYRINGE (DIRT ON THE WHITE PART OF THE PLUNGER). THIS WAS NOTICED PRIOR TO BEING USED. PER EMAIL: WE HAVE DISCOVERED FOURTEEN ISSUES FROM THE LAST SIX MONTHS OF THIS YEAR. PLEASE ACCEPT THIS EMAIL AS MY OFFICIAL NOTIFICATION OF OUR OBSERVATIONS AND I AM REQUESTING BD TO CONDUCT AN INVESTIGATION AND IF APPLICABLE IMPLEMENT A CAPA INTO THE OBSERVATIONS. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS. FOUR EMPTY 1ML BD SYRINGE -SLIP TIP IN TRAY WERE FOUND WITHOUT PLUNGERS IN THE SYRINGES BARREL. ONE EMPTY 3ML BD SYRINGE -LUER LOCK IN TRAY WAS FOUND WITH SOME TYPE OF CONTAMINANT. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH A GRADUATED MARKING DEFECT. ONE BLUNT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732218 ↗
• MalfunctionJun 25, 2019Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE IN THE BULK STERILE PHARMACY CONVENIENCE TRAY WAS FOUND WITH FOREIGN CONTAMINATES IN THE PACKAGING AND BARREL, AND A SCALE MARKING DEFECT ON THE BARREL BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN UNIDENTIFIED MATTERS WERE OBSERVED INSIDE TWO FILLED SYRINGES DURING PARTICULATE MATTER INSPECTION. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS. FOUR EMPTY 1ML BD SYRINGE -SLIP TIP IN TRAY WERE FOUND WITHOUT PLUNGERS IN THE SYRINGES BARREL. ONE EMPTY 3ML BD SYRINGE -LUER LOCK IN TRAY WAS FOUND WITH SOME TYPE OF CONTAMINANT. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH A GRADUATED MARKING DEFECT. ONE BLUNT FILL NEEDLE WITH FILTER WAS FOUND WITH SOME KIND OF DEFECT.

  Patient problems: No Information

  MAUDE report 8730919 ↗
• MalfunctionJun 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAY WERE FOUND WITH FOREIGN CONTAMINATES IN THE PACKAGING BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN UNIDENTIFIED MATTERS WERE OBSERVED INSIDE TWO FILLED SYRINGES DURING PARTICULATE MATTER INSPECTION. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS. FOUR EMPTY 1ML BD SYRINGE -SLIP TIP IN TRAY WERE FOUND WITHOUT PLUNGERS IN THE SYRINGES BARREL. ONE EMPTY 3ML BD SYRINGE -LUER LOCK IN TRAY WAS FOUND WITH SOME TYPE OF CONTAMINANT. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH A GRADUATED MARKING DEFECT. ONE BLUNT FILL NEEDLE WITH FILTER WAS FOUND WITH SOME KIND OF DEFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730915 ↗
• MalfunctionJun 20, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309701, BATCH NO. 8274580. IT WAS REPORTED THAT THERE WAS ISSUES WITH THE 1 ML BD SYRINGES SLIP TIP TRAY. SIX WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS, FOUR HAD MISSING PLUNGERS, AND ONE WAS FOUND WITH A SCALE MARKING ISSUE. PER RESPONSE EMAIL: ONE DIRTY LOOKING SYRINGE (DIRT ON THE WHITE PART OF THE PLUNGER). THIS WAS NOTICED PRIOR TO BEING USED. PER EMAIL: WE HAVE DISCOVERED FOURTEEN ISSUES FROM THE LAST SIX MONTHS OF THIS YEAR. PLEASE ACCEPT THIS EMAIL AS MY OFFICIAL NOTIFICATION OF OUR OBSERVATIONS AND I AM REQUESTING BD TO CONDUCT AN INVESTIGATION AND IF APPLICABLE IMPLEMENT A CAPA INTO THE OBSERVATIONS. SIX EMPTY 1ML BD SYRINGE -SLIP TIP TRAY WERE FOUND WITH DIFFERENT TYPES OF CONTAMINANTS. FOUR EMPTY 1ML BD SYRINGE -SLIP TIP IN TRAY WERE FOUND WITHOUT PLUNGERS IN THE SYRINGES BARREL. ONE EMPTY 3ML BD SYRINGE -LUER LOCK IN TRAY WAS FOUND WITH SOME TYPE OF CONTAMINANT. ONE EMPTY 1ML BD SYRINGE -SLIP IN TIP TRAY WAS FOUND WITH A GRADUATED MARKING DEFECT. ONE BLUNT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8718101 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4