N/A 302833Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00382903028337), received between May 9, 2018 and Jul 2, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED. THE DEFECTIVE UNIT WAS FOUND PRIOR TO DISPENSING/ADMINISTRATION. IT WAS NEVER ADMINISTERED TO A PATIENT, SO NO PATIENT HARM IS INVOLVED. MATERIAL # 302833, BATCH # 2332106. IT WAS REPORTED BY CUSTOMER THAT THERE WAS A PARTICULATE INSIDE THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE COMPLAINANT EXPLAINED THAT THERE WAS A PARTICULATE INSIDE THE SYRINGE AND PROVIDED A PHOTOGRAPH, WHICH CONFIRMS THE CUSTOMER¿S STATEMENT. STAQ PHARMA ASSIGNED A COMPLAINT NUMBER, (B)(4) , FOR THE COMPLAINT INVESTIGATION. AFTER RECEIVING THE DEFECTIVE SYRINGE FROM THE CUSTOMER, THE UNIT WAS SUBMITTED FOR PARTICLE ANALYSIS AND IDENTIFICATION AT MCCRONE ASSOCIATES, A THIRD-PARTY LABORATORY. PRELIMINARY REPORTS FROM MCCRONE ASSOCIATES STATED THAT THE UNKNOWN CONTAMINANT WAS DEEPLY EMBEDDED WITHIN THE WALL OF THE BARREL OF THE SYRINGE, WHICH REQUIRED USING A RAZOR BLADE AND A FINE TUNGSTEN NEEDLE TO ISOLATE THE CONTAMINANT FOR SAMPLE PREPARATION AND ANALYSIS. FT-IR AND SEM/EDS TESTS PERFORMED AT MCCRONE ASSOCIATES CONCLUDED THAT THE YELLOW-BROWN CONTAMINANT WAS VERY SIMILAR TO A MILLAD CLARIFYING AGENT OR OTHER SIMILAR MATERIAL, AND THEY ALS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656486 ↗
• MalfunctionJun 17, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS LEAKAGE PAST THE STOPPER/PLUNGER WHILE USING BD 30 ML LUER SLIP SYRINGE. THIS OCCURRED 8 TIMES, HOWEVER, NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE NURSE IN CHARGE FOUND FLUID LEAKAGE AT THE CONNECTION BETWEEN THE SYRINGE AND THE PISTON WHEN DRAWING THE NORMAL SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734755 ↗
• MalfunctionJan 14, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED BD LUER SLIP TIP SYRINGE HAD MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT SURE IF OTHER MARKETS HAVE BROUGHT THIS UP, BUT ONLY ONE SYRINGE HAS THE ML MAKINGS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257525 ↗
• MalfunctionNov 4, 2021Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT MOLD WAS DISCOVERED IN 10 BD LUER SLIP¿ SYRINGE TIP, 30 ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT HAS RECEIVED A COMPLAINT ABOUT 30ML SYRINGE NO. 302833 FROM (B)(6) RESEARCH INSTITUTE, AND 10 PROBLEMATIC SYRINGES HAVE BEEN COLLECTED THE CUSTOMER COMPLAINED OF SUSPECTED MOLD IN THIS BATCH OF SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755339 ↗
• MalfunctionSep 3, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SYRINGE 30ML LS S/C 56 EXPERIENCED ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NO. 9029908: 1 TUBE HAS ILLEGIBLE MARKINGS ON THE SCALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422300 ↗
• MalfunctionSep 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 37 SYRINGE 30ML LS S/C 56 EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NUMBER 8360688: 5 SYRINGES HAVE IMPURITIES IN THE BARREL, AND 6 SUSPECTED MOLDS ARE FOUND IN THE PACKAGING AND THE BARREL; LOT NO. 8360690: THERE ARE IMPURITIES IN THE BARREL OF 8 SYRINGES; LOT NO. 9029908: 1 SYRINGE HAS IMPURITIES IN THE BARREL AND PACKAGING, 3 SYRINGES HAVE IMPURITIES IN THE PACKAGING, 13 TUBES HAVE IMPURITIES, AND 1 SYRINGE HAS FOUND SUSPECTED MOLD ON THE PACKAGING AND THE BARREL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422298 ↗
• MalfunctionAug 1, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD¿ 30ML SLIP TIP SYRINGE PLUNGER ROD BROKE. THIS OCCURRED ON 20 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 SYRINGES WERE NOTICED WITH THE END OF PLUNGER ROD BROKEN DURING PRIMING. NO INJURY ON THE END USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8852532 ↗
• MalfunctionJun 18, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CRACKED BARREL AND FOREIGN MATTER OCCURRED BEFORE USE WITH SYRINGES 30 ML LS S/C 56. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT'S FOUND THAT THE BARREL TIP WAS CRACKED, THERE WAS WHITE MATERIAL IN SIDE OF THE BARREL AND THE PLUNGER WAS QUITE DIFFICULT TO MOVE. THERE WERE 3 SYRINGES AS SUCH." (UNUSED SYRINGES).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8709159 ↗
• MalfunctionMay 21, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES WHERE THE STOPPER WAS DEFORMED WITH A BD SYRINGE 30ML LS S/C 56. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER OPENING THE UNIT PACKAGE, IT WAS FOUND THAT STOPPER WAS OUT OF SHAPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629537 ↗
• MalfunctionMay 21, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN 10 BD¿ SLIP TIP SYRINGE BARRELS AFTER OPENING THEIR UNIT PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "AFTER OPENING THE UNIT PACKAGE, IT WAS FOUND THAT FOREIGN MATTER IN BARREL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629078 ↗
• MalfunctionMay 20, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD¿ SLIP TIP STERILE SYRINGE FLANGE WAS DAMAGED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENING THE UNIT PACKAGE, IT WAS FOUND THAT FLANGE DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624154 ↗
• MalfunctionMay 16, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO SYRINGE 30ML LS S/C 56 EXPERIENCED PRODUCT DAMAGE/DEFORMATION AND WAS STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER OPENING THE UNIT PACKAGE, IT WAS FOUND THAT THE FLANGE BROKEN , AND THE BROKEN PART ISN'T IN THE UNIT PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8616091 ↗
• MalfunctionMay 10, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON 50 SYRINGES 30ML LS S/C 56 FROM LOT # 8082819, AND 50 SYRINGES FROM LOT # 8082821, BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THIS HOSPITAL EQUIPMENT SECTION TEACHER COMPLAINS, RECEIVES EACH SECTION TEACHER TO REPORT THE SYRINGE WITH THE BROWN FOREIGN MATTER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8600157 ↗
• MalfunctionMar 22, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SYRINGE 30ML LS S/C 56 HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED, " IT WAS FOUND THAT FOREIGN MATTER ON BARREL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444359 ↗
• MalfunctionMar 12, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE 30ML LS S/C 56 EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER: VERBATIM: ¿NURSE FOUND THE BARREL WITH FOREIGN MATTER BEFORE USING.¿ SEE PR FOR ADDITIONAL DETAILS. COMPLAINT SUMMARY DETAIL: THIS IS MDR REPORTABLE. IF FOREIGN MATTER PARTICLES ARE IN THE FLUID PATH OR ON THE CANNULA IT MAY HAVE THE POTENTIAL TO ENTER THE BLOOD STREAM OF AN INDIVIDUAL AND POSSIBLY CAUSE HARM I.E. EMBOLISM, INFECTION, ETC. EVENT TYPE: FOREIGN MATTER / MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413446 ↗
• MalfunctionJan 11, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD¿ SLIP TIP STERILE SYRINGE THERE WAS AN ISSUE WITH BARREL WITH BROWN FOREIGN MATTER.

  Patient problems: No Information

  MAUDE report 8242267 ↗
• MalfunctionJan 10, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD¿ SLIP TIP STERILE SYRINGE THERE WAS AN ISSUE WITH BARREL WITH BROWN FOREIGN MATTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233280 ↗
• MalfunctionJan 8, 2019Break; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD¿ SLIP TIP SYRINGE BARREL TIP WAS FOUND DAMAGED BEFORE USE WITH PLASTIC-LIKE FOREIGN MATTER ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227575 ↗
• MalfunctionDec 27, 2018Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT BD¿ SYRINGE LS S/C 56 HAD TAWNY FOREIGN MATTER IN ONE BARREL AND INK IN 3 BARRELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199972 ↗
• MalfunctionMay 9, 2018Break; Device Markings/Labelling Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NURSE FOUND THREE DEFECTS IN A BD¿ SLIP TIP SYRINGE. ¿BLACK FOREIGN MATTER IN SYRINGE BARREL AND BROWN FOREIGN MATTER IN BARREL TIP; PRINTING SCALE WAS NOT WELL PRINTED; FLANGE DAMAGED¿. THE DEVICE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500576 ↗

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-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-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-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-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