BD Luer-Lok 309628Recalls & reported problems

Summary

The FDA's MAUDE database contains 862 adverse event reports that list this exact device (DI 00382903096282), received between Oct 25, 2017 and Sep 30, 2026 — classified as 13 injuries, 849 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (187 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 862 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954907 ↗
• MalfunctionSep 22, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860022 ↗
• MalfunctionSep 18, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827374 ↗
• MalfunctionSep 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827372 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808577 ↗
• MalfunctionSep 17, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808545 ↗
• MalfunctionSep 16, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794658 ↗
• MalfunctionSep 16, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794645 ↗
• MalfunctionSep 16, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790352 ↗
• MalfunctionSep 15, 2026Contamination /Decontamination Problem

  It was reported that BD SYRINGE 1ML LL contained foreign matter.Verbatim:complaint via email. Email(s) attached.Manufactured product had two particulates found. Probable cause cellulose fiber in syringes used. On (b)(6)26, during visual inspection of the final product bags, MFG operator identified a particulate in product bag 2 and QA Ops Specialist identified a particulate in product bag 1. The particulate in Bag 1 was not able to be identified using the library. The particulate in Bag 2 was determined to be an intrinsic particle. Both bags were rejected. Per the investigation - The 6M Root Cause Analysis determinedMaterials to be the primary root cause of both of these particulates. The particle in Bag 1 was determined to have potentially interacted with the Human Male AB Serum (hABS) used. The particle in Bag 2 was identified to be found in syringes during a rinse study performed by ElevateBio. The textile cellulose fiber in Bag 2 is considered a typical extrinsic particulate as it can be attributed to the vendor manufacturing process, but is not a part of the material of construction of the raw material itself. Sinking white and black particulates are not expected as a part of

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773777 ↗
• MalfunctionSep 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741614 ↗
• MalfunctionSep 11, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735884 ↗
• MalfunctionAug 26, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456189 ↗
• MalfunctionAug 26, 2026Contamination

  It was reported that BD SYRINGE 1ML LL contained foreign matter.Complaint via email. x has received a product complaint related to an Eylea 8mg Vial kit.Kindly acknowledge receipt of this request and send us the complaint investigation reference number and due date when available. Complaint Number:Complaint Description:Catalog & Lot number:Investigational Request /Return Component Status:(b)(4).On (b)(6)2026 x was informed of an event with Eylea 8mg vial kit which was categorized with the defect Foreign Matter FM - Syringe.On (b)(6)2026, x was notified of an event: ¿it was a faulty syringe. The person drawing it up didn't notice it had a black mark on the inside of it¿.8542800023.Injection Needle.Catalog: 309628.Lot: 3152795.Please perform an evaluation of their process to include the release inspection process and controls in place that would prevent deformed rubber stoppers. A sample is available and will be forwarded for further evaluation.Impact to patient: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50445094 ↗
• MalfunctionAug 20, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355512 ↗
• MalfunctionAug 7, 2026Contamination

  No additional information was provided

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169556 ↗
• MalfunctionAug 7, 2026Contamination

  No additional information was provided

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169555 ↗
• MalfunctionAug 7, 2026Contamination

  No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169554 ↗
• MalfunctionAug 7, 2026Contamination

  No additional information was provided

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169552 ↗
• MalfunctionAug 7, 2026Contamination

  No additional information was provided

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169550 ↗
• MalfunctionAug 7, 2026Contamination

  It was reported that BD SYRINGE 1ML LL contained foreign matter.It was reported that a formal complaint received from one of our customers concerning the recurring presence of particles and plastic-like inclusions inside BD 1 mL syringes.Most recently, our customer observed a plastic-like particle inside a 1 mL syringe during the production of prefilled syringes. The particle became visible after the medicinal product had already been filled into the syringe. Upon closer inspection, the particle appeared to be floating freely inside the syringe.According to our customer, this is not an isolated incident. Including the most recent event, a total of nine deviations have been documented within approximately one year involving particles inside these syringes. As the syringes are inspected for air bubbles and particles after production, several affected syringes had to be rejected and remanufactured.The recurring nature of these findings may indicate a manufacturing or quality issue. We therefore kindly request that BD conduct a thorough investigation, including a root cause analysis, and provide us with the results as well as any proposed corrective and preventive actions.The relevant

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169549 ↗
• MalfunctionJun 29, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 1ML LL HAD LEAKAGE PAST THE STOPPER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 31MAR2026 X WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE, CI-DULL INJECTION NEEDLE ON 31MAR2026, X MEDICAL INFORMATION WAS NOTIFIED OF AN EVENT: "THE NEEDLE WAS TOO BLUNT ADDITIONAL INFORMATION: FOR THE REPORTED OBSERVATION OF MOISTURE BEHIND THE PLUNGER, IF THIS ISSUE HAS ALREADY BEEN REPORTED TO BD, PLEASE PROVIDE THE CORRESPONDING REFERENCE NUMBER. PLEASE PROVIDE REFERENCE NUMBERS AS THIS WAS NOT PREVIOUSLY REPORTED. IF THE ISSUE HAS NOT BEEN PREVIOUSLY REPORTED, KINDLY SHARE THE MATERIAL NUMBER AND BATCH/LOT NUMBER OF THE SYRINGE INVOLVED. 309628 : 3324199 PLEASE CONFIRM WHETHER THE SYRINGE SAMPLE HAS ALREADY BEEN RETURNED TO US. IF NOT, KINDLY LET US KNOW IF YOU REQUIRE AN ADDITIONAL SHIPPING LABEL FOR ITS RETURN. SAMPLE WILL BE SHIPPED LATER TODAY. SHIPPING LABEL HAS ALREADY BEEN PROVIDED AND IT NOT REQUIRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25657704 ↗
• MalfunctionMay 20, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. ON 21APR2026 X WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM - SYRINGE. ON 21APR2026, X MEDICAL INFORMATION WAS NOTIFIED OF AN EVENT: ¿THERE IS BROWN STAINING ON THE SYRINGE.¿ CATALOG: 309628. LOT: 3122727. A SAMPLE WILL NOT BE FORWARDED TO BD AT THIS TIME. IMPACT TO PATIENT: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231379 ↗
• MalfunctionMay 18, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 1ML LL HAD LEAKAGE. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE INITIATE A COMPLAINT INVESTIGATION AND HAVE IT COMPLETED WITHIN 45-60 DAYS REFERENCING X FOR ¿LEAKING SYRINGE ¿. THIS IS FOR SYRINGE LOTS 5056026, 3034733. I AM TRYING TO CONFIRM IF PHOTOS OR A COMPLAINT SAMPLE ARE AVAILABLE. PLEASE INCLUDE: RECORD NUMBER: BATCH RECORD REVIEW, MANUFACTURING UNPLANNED DEVIATIONS, BULK RETAIN SAMPLE INSPECTION, ANALYTIC RESULTS, COMPLAINT HISTORY, ROOT CAUSE, CONFIRMED OR NOT CONFIRMED. IF ISSUES MAY OCCUR THAT MAY RESULT IN A DELAY IN THE REPORT TO EXCEED 45 DAYS, PLEASE PROVIDE AN INTERIM STATUS REPORT. (B)(6) 2026: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2026. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? IZERVAY. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? THE LEAK OCCURRED AFTER THE MEDICATION WAS WITHDRAWN FROM THE VIAL. BEFORE ADMINISTRATION TO THE PATIENT. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES, ANOTHER KIT HAD TO BE USED BY THE HCP. RESPONSE RECEIVE ON (B)(6) 2026: WAS THERE ANY VISIBLE CRACKS OR DAMAGED SEEN ON SYRINGE? THE TECHNI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201461 ↗
• MalfunctionMay 18, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 1ML LL HAD LEAKAGE. COMPLAINT VIA EMAIL. PLEASE INITIATE A COMPLAINT INVESTIGATION AND HAVE IT COMPLETED WITHIN 45-60 DAYS REFERENCING X FOR ¿LEAKING SYRINGE¿. THIS IS FOR SYRINGE LOTS 5056026, 3034733. I AM TRYING TO CONFIRM IF PHOTOS OR A COMPLAINT SAMPLE ARE AVAILABLE. PLEASE INCLUDE: RECORD NUMBER: BATCH RECORD REVIEW, MANUFACTURING UNPLANNED DEVIATIONS, BULK RETAIN SAMPLE INSPECTION, ANALYTIC RESULTS, COMPLAINT HISTORY, ROOT CAUSE, CONFIRMED OR NOT CONFIRMED. IF ISSUES MAY OCCUR THAT MAY RESULT IN A DELAY IN THE REPORT TO EXCEED 45 DAYS, PLEASE PROVIDE AN INTERIM STATUS REPORT. 30-APR-2026: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 20APR2026 WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? IZERVAY WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? THE LEAK OCCURRED AFTER THE MEDICATION WAS WITHDRAWN FROM THE VIAL. BEFORE ADMINISTRATION TO THE PATIENT. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES, ANOTHER KIT HAD TO BE USED BY THE HCP. RESPONSE RECEIVE ON 14-MAY-2026: WAS THERE ANY VISIBLE CRACKS OR DAMAGED SEEN ON SYRINGE? THE TECHNICIAN DID NOT NOTE ANY CRACKS OR DA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201459 ↗