BD Luer-Lok 309695Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00382903096954), received between Nov 10, 2017 and Mar 23, 2026 — classified as 3 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT THE SYRINGE CONTROL 10ML LL BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309695 BATCH#: UNKNOWN. VERBATIM: CATH LAB DID NOT APPROVE FROM THE CROSS FROM PART# CCX010 TO PART# 309695 BECAUSE ¿THE PRESSURE WHEN PUSHING CONTRAST THROUGH WAS BENDING THE SYRINGE AND BROKE A HANDLE OFF FOR THE CLINICAL QUALITY¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663554 ↗
• MalfunctionMar 17, 2026Crack; Leak/Splash

  IT WAS REPORTED THAT BD 309695 - SYRINGE CONTROL 10ML LL BARREL CRACKED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION: MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026. TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE). LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT. (B)(6) OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: SURGEON WAS INJECTING LOCAL ANESTHETIC USING THE 10CC CONTROL TOP SYRINGE. THE SYRINGE CRACKED WHILE SHE WAS INJECTING AND LOCAL SPRAYED OUT. WHO WAS AFFECTED? NO PERSON AFFECTED. FREQUENCY OF PROBLEM: FIRST TIME. INVASIVE PROCEDURE? YES. PROCEDURE: DILATION AND CURETTAGE. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP FINGER CONTROL 10ML. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 309695. SERIAL OR LOT NUMBER: (B)(4). EXPIRY DATE: 2030-08-31. SUPPLIER: MEDLINE CANADA CORPORATION: SUPPLIER/CATALOGUE NUMBER: 308-309695. IS THE DEVICE RETAINED? YES. INVESTIGATION REQUEST: EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED; LOT REVIEW. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619134 ↗
• MalfunctionFeb 2, 2026Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239974 ↗
• MalfunctionFeb 2, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BD SYRINGE CONTROL 10ML LL PLUNGER WAS BROKEN/ DAMAGED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING MEDICATION ADMINISTRATION, THE PHYSICIAN WAS USING A BD 10 ML CONTROL SYRINGE WHEN THE FINGER LOOPS BROKE OFF. THE SYRINGE MALFUNCTION OCCURRED MID-ADMINISTRATION, RESULTING IN A BRIEF DELAY OF THE PROCEDURE. THE REMAINING MEDICATION WAS TRANSFERRED TO A NEW SYRINGE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. SIMILAR ISSUES WITH BD 10 ML CONTROL SYRINGES HAVE BEEN REPORTED BY TWO OTHER SURGEONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238169 ↗
• MalfunctionDec 8, 2025Break; Break

  NO MEDICAL INTERVENTION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751435 ↗
• MalfunctionNov 18, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL HAD A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309695; BATCH#: 5177721. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE A PRODUCT CONCERN FOR 309695 10ML CONTROL SYRINGE, LOT# 5177721. PACKAGING IS COMING APART AT THE SEAM. STERILITY IS COMPROMISED. ADDITIONAL INFO RECEIVED ON 31-0CT: THIS HAPPENED ON 10/26. I DO NOT HAVE AN IMAGE OF THE PRODUCT COMING APART AT THE SEAM BUT I DO HAVE A SAMPLE. WE HAVE HAD SEVERAL OCCURRENCES OF THIS NATURE WITH THIS SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581806 ↗
• MalfunctionNov 18, 2025Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581797 ↗
• MalfunctionJul 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309695, LOT#: 5121447. IT WAS REPORTED BY CUSTOMER THAT ITEM IS BUSTED OPEN INSIDE THE INDIVIDUAL PLASTIC BAGS. RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 309695, QUANTITY AFFECTED: 1 BX, SERIAL/LOT NUMBER: (B)(6), PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ITEM IS BUSTED OPEN INSIDE THE INDIVIDUAL PLASTIC BAGS. SHIPPING BOXES ARE NOT DAMAGED AND IT IS ONLY SOME OF THE SYRINGES. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER RESPONSE ON (B)(6) 2025. THIS ISSUE WAS DISCOVERED ON (B)(6) 2025. AS FOR HOW MANY WERE AFFECTED, MAYBE 5 BUT I WAS UNCOMFORTABLE USING ANYTHING FROM THAT BOX SO I REPLACED ALL OF THEM AND SEALED IT SHUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475805 ↗
• MalfunctionJul 10, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309695, LOT#: 5121447. IT WAS REPORTED BY CUSTOMER THAT ITEM IS BUSTED OPEN INSIDE THE INDIVIDUAL PLASTIC BAGS. RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO, ITEM: 309695, QUANTITY AFFECTED: 1 BX, SERIAL/LOT NUMBER: (B)(6), PO: (B)(4), ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ITEM IS BUSTED OPEN INSIDE THE INDIVIDUAL PLASTIC BAGS. SHIPPING BOXES ARE NOT DAMAGED AND IT IS ONLY SOME OF THE SYRINGES. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER RESPONSE ON (B)(6) 2025. THIS ISSUE WAS DISCOVERED ON (B)(6) 2025. AS FOR HOW MANY WERE AFFECTED, MAYBE 5 BUT I WAS UNCOMFORTABLE USING ANYTHING FROM THAT BOX SO I REPLACED ALL OF THEM AND SEALED IT SHUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475799 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309695. BATCH # 5016854. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WANTED TO BRING TO YOUR ATTENTION FEEDBACK THAT WE RECEIVED FROM REGARDING BD 10ML CONTROL SYRINGE -PRODUCT #3096-95 & LOT #5016854. "WE HAVE HAD SEVERAL CONTROL SYRINGES THAT HAVE BROKEN AS MEDICATION WAS BEING INJECTED DURING A SURGICAL PROCEDURE. THE PIECES BREAK OFF AND FLY ACROSS THE ROOM, WHICH COULD LEAD TO CONTAMINATION ISSUES AND/OR SAFETY ISSUES IF PIECES GET LEFT IN THE SURGICAL FIELD." ADDITIONAL INFORMATION PROVIDED: WE HAVE HAD TWO SURGEONS ON TWO DIFFERENT OCCASIONS THAT HAVE HAD ISSUES WITH THE CONTROL SYRINGES, MORE SPECIFICALLY THEY FELL APART AS THE SURGEONS WERE INJECTING MEDICATION. ONE BROKE IN HALF WITH PART OF IT FLYING OFF AND BOUNCING OFF THE WALL. THE SURGEONS HAVE REQUESTED A REPLACEMENT AND NO LONGER WANT TO USE THIS PRODUCT. IT IS A POTENTIAL FOR PATIENT HARM AS IT COULD LEAD TO CONTAMINATION IF IT BOUNCED BACK ON THE STERILE FIELD, OR PIECES COULD POTENTIALLY BE LEFT INSIDE THE PATIENT. I DO NOT HAVE SPECIFIC DATES, NOR DO WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413578 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309695. BATCH # 5016854. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WANTED TO BRING TO YOUR ATTENTION FEEDBACK THAT WE RECEIVED FROM REGARDING BD 10ML CONTROL SYRINGE -PRODUCT #3096-95 & LOT #5016854. "WE HAVE HAD SEVERAL CONTROL SYRINGES THAT HAVE BROKEN AS MEDICATION WAS BEING INJECTED DURING A SURGICAL PROCEDURE. THE PIECES BREAK OFF AND FLY ACROSS THE ROOM, WHICH COULD LEAD TO CONTAMINATION ISSUES AND/OR SAFETY ISSUES IF PIECES GET LEFT IN THE SURGICAL FIELD." ADDITIONAL INFORMATION PROVIDED: WE HAVE HAD TWO SURGEONS ON TWO DIFFERENT OCCASIONS THAT HAVE HAD ISSUES WITH THE CONTROL SYRINGES, MORE SPECIFICALLY THEY FELL APART AS THE SURGEONS WERE INJECTING MEDICATION. ONE BROKE IN HALF WITH PART OF IT FLYING OFF AND BOUNCING OFF THE WALL. THE SURGEONS HAVE REQUESTED A REPLACEMENT AND NO LONGER WANT TO USE THIS PRODUCT. IT IS A POTENTIAL FOR PATIENT HARM AS IT COULD LEAD TO CONTAMINATION IF IT BOUNCED BACK ON THE STERILE FIELD, OR PIECES COULD POTENTIALLY BE LEFT INSIDE THE PATIENT. I DO NOT HAVE SPECIFIC DATES, NOR DO WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413396 ↗
• MalfunctionMay 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT CODE: 309695. PRODUCT DESCRIPTION: SYRINGE CONTROL 10CC L/L BX/25 P39. LOT/SERIAL #: (B)(6). EXPIRY DATE: UNKNOWN. PROBLEM INFORMATION PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: 07-APR-2025 CONCERN DESCRIPTION: INSIDES OF SYRINGE PACKAGE ARE SOILED. OCCURRENCES: 3 EA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082699 ↗
• MalfunctionFeb 14, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL#: 309695, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD LUER-LOK HAD LABEL CONTENT MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THERE IS NO EXPIRATION DATE ON THE SYRINGE, AND THE ONLY YEAR PRINTED ON THE PACKAGING IS 2003. ADDITIONAL INFORMATION PROVIDED: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. WAS THERE ANY LEAK? NO. 3. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? MULTIPLE DATES. 4. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? WE DO NOT HAVE PACKAGING ANYMORE. 5. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384839 ↗
• MalfunctionFeb 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369726 ↗
• MalfunctionJan 15, 2025Packaging Problem; Packaging Problem

  MATERIAL# (B)(4), BATCH# 4234195 . IT WAS REPORTED THAT THE BD LUER-LOK PACKAGE SEAL INTEGRITY WAS POOR / QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THERE WERE ALSO 4 SAMPLES OF LOT 4234195 RECEIVED AND RETAINED IN VH. THESE SAMPLES HAD THE SAME ISSUE. "NOT FULLY SEALED AROUND THE EDGES" THE PR WAS CREATED BASED ON THE ADDITIONAL SAMPLE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158718 ↗
• MalfunctionJan 3, 2025Defective Component; Defective Component

  MATERIAL #:309695. BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL PLUNGER ROD BENDS EASILY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. 309695. C-241-27. THE PLUNGERS FOLDED. WAS USED ON A PATIENT HAPPENED ON (B)(6). ADDITIONAL INFORMATION PROVIDED: 1. PLEASE PROVIDE THE DATE OF EVENT. 12/3/2024. 2. PLEASE PROVIDE THE BATCH# OR LOT# NUMBER? PACKAGE NOT AVAILABLE BUT PRODUCT SENT BACK TO BD. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM BUT PHYSICIAN DID RECEIVE A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21066589 ↗
• MalfunctionDec 30, 2024Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044739 ↗
• MalfunctionDec 21, 2024Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20996948 ↗
• MalfunctionDec 21, 2024Packaging Problem; Packaging Problem

  MATERIAL #:309695 BATCH#:4214856. IT WAS REPORTED THAT THE BD LUER-LOK PACKAGE SEAL INTEGRITY WAS POOR / QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONCERNS WITH SEAL. REF 209695 LOT 4214856 "WEVE BEEN CONSISTENTLY GETTING DEFECTIVE BD 10ML CONTROL SYRINGES REF 209695 WITH THE LOT 4214856. WEVE PROBABLY HAD 6-7 NOW THAT ARE NOT FULLY SEALED AROUND THE EDGES. I THINK THIS NEEDS TO GET ESCALATED TO BD TO RECALL THIS LOT. LET ME KNOW WHAT OTHER INFO YOU NEED." "I HAVE 4 MORE OF THESE WITH THE SAME LOT #. " ADDITIONAL INFORMATION PROVIDED: 1. PLEASE PROVIDE THE DATE OF EVENT. 11.12.24 & 11.25.24 2. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? (B)(4), ATTN: (B)(6). 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20996941 ↗
• MalfunctionNov 19, 2024Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727373 ↗
• MalfunctionOct 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL # 309695; BATCH # 4122242. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. JUST WANT TO BRING THIS TO YOUR AWARENESS, BELOW ARE PICS OF SIN# 362157 STERILE CONTROL SYRINGE 10ML. WHEN THE OR TEAM OPENED IT, IT WAS DIRTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20445541 ↗
• MalfunctionSep 27, 2024Packaging Problem; Packaging Problem

  MATERIAL # 309695, BATCH # 4179466, 4164479. IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL PACKAGE SEAL INTEGRITY WAS POOR / QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED THE SEAL AROUND THE EDGE OF THE STERILE PACKAGING IS FAILING, CAUSING STERILITY ISSUES IN PROCEDURE ROOMS/OPERATING ROOMS. EVENT DATE: 9-11-2024, PRODUCT NAME: ITM-1150085 - SYRINGE 10ML CONTROL, PRODUCT REF: (B)(4), LOT NUMBERS: 4179466 AND 4164479, BD CUSTOMER ACCOUNT NUMBER: (B)(6), LOT 4179466: (B)(4) EACHES, LOT 4164479: (B)(4) EACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320842 ↗
• MalfunctionJul 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 309695, BATCH NUMBER#: UNKNOWN. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: 309695, QUANTITY AFFECTED: (B)(4) CASE, SERIAL/LOT NUMBER:UNKNOWN, PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. . REPORTED ISSUE: ONE BD SYRINGE TO BE DEFECTIVE, HAS UNUSUAL STAIN INSIDE OF PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745318 ↗
• MalfunctionJul 13, 2024Microbial Contamination of Device; Microbial Contamination of Device

  MATERIAL: 309695, BATCH#: 4088628. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: I HAVE A DEFECTIVE PRODUCT TO REPORT AND HAVE A SAMPLE TO SEND BACK FOR QC. THE REASON FOR THE DELAY IN FILING IS THAT I HAD TO FIND THE CORRECT PERSON TO REPORT IT TO¿. DATE: (B)(6) 2024. MFG BD. PRODUCT BD 10 ML CONTROL SYRINGE. PRODUCT #309695. LOT# 4088628. EXPIRE 2-28-29. CHALLENGE DIRT/MILDEW INSIDE STERILE PACKAGE. THIS HAS NOT BE OPENED AND AVAILABLE TO RETURN TO BD. PLEASE ADVISE ON NEXT STEPS. CUSTOMER RESPONSSE: DATE: (B)(6) 2024, MFG BD, PRODUCT BD 10 ML CONTROL SYRINGE, PRODUCT # 309695, LOT# 4088628, EXPIRE 2-28-29, CHALLENGE DIRT/MILDEW INSIDE STERILE PACKAGE. THERE WERE NO ADVERSE EVENT SINCE THIS WAS CAUGHT BEFORE IT WAS OPENED IN THE OR. THIS HAS NOT BE OPENED AND AVAILABLE TO RETURN TO BD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736985 ↗
• MalfunctionJun 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIALS#: 309695 BATCH#: 4094819 IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE PURCHASE OUR SYRINGES FROM OUR DISTRIBUTOR XXXXXXX- (OUR DSM, AND LOCAL REP ARE INCLUDED AS WELL) TODAY WE WERE BROUGHT A PERFECTLY SEALED AND STERILE 10ML CONTROL SYRINGE, PART # 309695- LOT # 40948191 THANKFULLY, IT WAS DISCOVERED PRIOR TO A PROCEDURE. THERE IS SOME RESIDUE OR DRIED FLUID OF SOME TYPE, ON THE FINGER LOOP ARE OF THE PLUNGER, THE PACKAGE IS STILL PERFECTLY SEALED. I AM INCLUDING PICTURES OF THE EFFECTED COMPONENT. WE WOULD LIKE TO GENERATE AN OFFICIAL PRODUCT COMPLAINT AND WOULD LIKE TO SEND IN THE PRODUCT DIRECTLY TO BECTON DICKSON FOR EVALUATION. I AM CURRENTLY WAITING ON MY ONLINE ACCESS TO COMPLETE THE COMPLAINT FORM. IF YOU COULD PLEASE EMAIL ME TO FORM FOR NOW, I WOULD APPRECIATE IT. AS I SAID PREVIOUSLY, I AM ALSO ATTACHING OUR DISTRIBUTOR DSM (DESIGNATED SERVICE MANAGER) , AS WELL AS OUR REP AS AN FYI AND THEIR RECORDS AS WELL, BUT WOULD LIKE TO SEND THIS DIRECTLY TO THE QUALITY REVIEW DEPARTMENT AT BD. PLEASE SEND EMAIL THE SPECIFIC FORMS THAT NEED COMPLETED AND SHIPPING INFORMATION, SO THAT WE CAN G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582077 ↗

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-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-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-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-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-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