BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 8879589 · Received August 9, 2019

    Report

    Report Number
    1911916-2019-00790
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 22, 2019
    Report Date
    July 29, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THREE (3) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) SAMPLE WAS RETURNED IN AN UNSEALED BLISTER PACK AND THE OTHER TWO (2) SAMPLES WERE RETURNED IN SEALED BLISTER PACKS. ALL THREE (3) SAMPLES WERE VISUALLY EXAMINED USING 10X MAGNIFICATION AND FOREIGN MATTER WAS OBSERVED BETWEEN THE RIBS OF THE STOPPERS OR IN THE FLUID PATH OF THE BARRELS. THE FOREIGN MATTER WAS VISUALLY IDENTIFIED AS PLASTIC SHAVINGS. PLASTIC DUST MAY BE CREATED THROUGHOUT THE MANUFACTURING PROCESS VIA CONVEYING AND VIBRATION OF PLASTIC COMPONENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER (FM) FOR LOT #8082797 ITEM #302832. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. RATIONALE: BD ACKNOWLEDGES THAT THERE WAS FOREIGN MATTER IN THE SAMPLES RETURNED BY THE CUSTOMER. AS THE THREE (3) TOTAL OCCURRENCES WOULD NOT EXCEED THE ACCEPTABLE QUALITY LEVEL (AQL) OF ¿FOREIGN MATTER ¿FLUID PATH PARTICLES > 1/64 IN = 0.65%¿ FOR THE BATCH, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 30ML LL S/C 56 EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 302832, BATCH NO: 8082797. VERBATIM: PHARMACIST FROM FACILITY CALLED TO REPORT THAT THEY FOUND A WHITE FOREIGN SUBSTANCE IN BETWEEN THE STOPPER AND BARREL INSIDE THE SYRINGE. HE SAID IT LOOKED "LIKE COTTON, STRINGY, COULD HAVE BEEN PLASTIC". THIS OCCURRED ON 1 SYRINGE ON (B)(6) 2019 DURING DRAWING OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673405 SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8082797 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other