BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 26X3/8 IB

    MDR report key: 11033461 · Received December 17, 2020

    Report

    Report Number
    1911916-2020-01126
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    May 15, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051106
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER: 9193538. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. IT COULD BE POSSIBLE THAT WHILE PASSING THE NEEDLE THROUGH THE STOPPER VIAL/ CARTRIDGE THE NEEDLE GOT CLOGGED WITH THE STOPPER MATERIAL. DURING THE MANUFACTURING PROCESS A VISION SYSTEM IS INSPECTING 100% ALL THE PRODUCTS FOR CLOGGED NEEDLES. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT, AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD NEEDLE 26X3/8 IB THE PLUNGER WOULD NOT DEPRESS. THIS OCCURRED ON 10 SEPARATE OCCASIONS, HOWEVER, THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLES WERE NOT WORKING PROPERLY AND WERE NOT ALLOWING FOR THE PLUNGER TO BE DEPRESSED. CALLER REPORTED 10 NEEDLES NOT WORKING PROPERLY WHEN TRYING TO DELIVER INSULIN. CALLER STATED IT IS NOT FILL RESISTANCE, CALLER CAN INSERT NEEDLE INTO SEPTUM, BUT SHE CANT PUSH THE PLUNGER TO DELIVER THE INSULIN. CALLER STATES THAT WHEN SHE CHANGES THE NEEDLE THEN SHE IS ABLE TO PUSH THE PLUNGER AND INSERT THE INSULIN INTO THE CARTRIDGE. 1ST EVENT DATE WAS ON (B)(6) 2020, CUSTOMER CANT REMEMBER OTHER EVENT DATES. CUSTOMER STATES THAT 10 NEEDLES HAVE FAILED FROM 5-15-2020 THRU TODAY 11-17-2020. CUSTOMER STATES THAT HER BG WAS 220 MG/DL FOR ALL EVENTS. NUMBER OF OCCURRENCES: 10. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PRODUCT WITH ISSUE BD 26 G, 3/8"" NEEDLE, PN 305110 FOR ALL 10 NEEDLES. PRODUCT LOT #: SAME LOT #: 9193538. DID ISSUE CAUSE ANY INJURY? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493491 BD NEEDLE 26X3/8 IB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9193538 00382903051106

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR