BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10590955 · Received September 26, 2020

    Report

    Report Number
    8041187-2020-00620
    Event Type
    Malfunction
    Date Received
    September 26, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/1/2020. H.6. INVESTIGATION: TWENTY REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES WERE SUBJECTED TO LEAKAGE TESTING. NO LEAKAGE WAS OBSERVED FROM THIS TEST. THEREFORE, THE TEAM WAS UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE. A DEVICE HISTORY REVIEW WAS NOT ABLE TO BE PREFORMED AS THIS BATCH WAS PRODUCED IN 2003 AND THE RECORD RETENTION PERIOD IS SEVEN YEARS. THE TEAM WAS NOT ABLE TO DETERMINE A ROOT CAUSE AS THIS FAILURE WAS NOT VERIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309628 BATCH NO. 3223171. DISTRIBUTOR HAS CUSTOMER WHO USED BD LUER-LOK¿ 1-ML SYRINGE 309628 AND NOTED IT'S PLUNGER DID NOT HAVE ENOUGH RESISTANCE TO KEEP FLUID IN AND WANTED ANY TROUBLESHOOTING TIP BD COULD OFFER. CUSTOMER PURCHASED BOX OF 100 WITH LOT 3223171 NOTED. EXPLAINED TO CALLER THERE ARE NO TROUBLESHOOTING TIP TO OFFER AS THERE SHOULD BE SOME RESISTANCE WITH THESE SYRINGES. SUGGESTED SHE HAVE CUSTOMER KEEP PRODUCT IN QUESTION AS A COMPLAINT WOULD BE FILED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 1 ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309628, BATCH NO. 3223171. DISTRIBUTOR HAS CUSTOMER WHO USED BD LUER-LOK¿ 1-ML SYRINGE 309628 AND NOTED IT'S PLUNGER DID NOT HAVE ENOUGH RESISTANCE TO KEEP FLUID IN AND WANTED ANY TROUBLESHOOTING TIP BD COULD OFFER. CUSTOMER PURCHASED BOX OF 100 WITH LOT 3223171 NOTED. EXPLAINED TO CALLER THERE ARE NO TROUBLESHOOTING TIP TO OFFER AS THERE SHOULD BE SOME RESISTANCE WITH THESE SYRINGES. SUGGESTED SHE HAVE CUSTOMER KEEP PRODUCT IN QUESTION AS A COMPLAINT WOULD BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055671 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 309628 3223171 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other