BD Luer-Lok 309629Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903096290), received between Feb 15, 2018 and Mar 24, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INJECTION THE RUBBER STOPPER SEPARATED FROM PLUNGER WITH A BD SYRINGE INSULIN 1ML LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING A BOTOX INJECTION THE RUBBER STOPPER CAME LOOSE FROM THE PLUNGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9873834 ↗
• MalfunctionSep 30, 2019Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT THE SYRINGE INSULIN 1ML LL "LOCKED UP" DURING USE WITH THE FLU VACCINE, AS THE PLUNGER ROD REQUIRED A LOT OF FORCE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THEIR CHARGE NURSES SAID THAT WHEN THEY USE THE FLU VACCINE (PICTURE ATTACHED) WITH THE BD 1ML SYRINGE 309629, THE SYRINGE ¿LOCKS UP¿ WHEN THEY TRY TO INJECT THE VACCINE. I PERSONALLY WATCHED A FLU VACCINE ADMINISTRATION AND THE PLUNGER ROD COULD NOT BE PRESSED WHEN THE FLU VACCINE WAS IN THE SYRINGE UNLESS THERE WAS A LOT OF FORCE. SHE SAID THEY HAVE BEEN NOTICING THIS FOR APPROXIMATELY THE LAST TWO WEEKS. THEY SAID THEY HAVE NOTICED SOME BRUISING TO THE PATIENT AS A RESULT. WHEN THEY USE A 3ML THEY DO NOT EXPERIENCE THE ¿LOCKING¿. THEY DON¿T THINK ITS AN ISSUE WITH THE 1 ML BUT SOMEHOW PERHAPS THE COMBINATION OF THE FLU VACCINE AND THE 1ML.

  Patient problems: Bruise/Contusion

  MAUDE report 9134587 ↗
• MalfunctionFeb 15, 2018Device Markings/Labelling Problem

  IT WAS REPORTED BY THE NURSE THAT THE BD LUER-LOK¿ SYRINGE HAS TICK MARKS THEN STARTS AT 10 UNITS. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275309 ↗