BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 11701758 · Received April 21, 2021

    Report

    Report Number
    1920898-2021-00438
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0083446. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-06-01. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2021 . AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON (B)(6) 2021 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. INVESTIGATION SUMMARY: CUSTOMER RETURNED FOUR SYRINGES IN A POUCH LABELED FOR 0.5ML, 31 GAUGE, 8MM SYRINGES FROM LOT 0083446. TWO SYRINGES FEATURED THEIR NEEDLE SHIELDS AND HUBS HAVING SEPARATED FROM THE ASSOCIATED BARRELS. THE HUBS HAVE BECOME LODGED INSIDE THEIR RESPECTIVE SHIELDS. THERE IS NO DAMAGE TO EITHER OF THE CONNECTORS AT THE DISTAL TIPS OF THE BARRELS OR THEIR NEEDLE HUBS. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND TO THE REMAINING TWO SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083446. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200886395, 200886116] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. ROOT CAUSE DESCRIPTION: BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLES MISSING BY WAY OF THE NEEDLE HUBS SEPARATING FROM THE BARREL. RATIONALE: CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL NEEDLE WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328509 BATCH NO. 0083446, UNKNOWN. IT WAS REPORTED THAT NEEDLE WAS MISSING FROM SYRINGE. VERBATIM: RELION CONSUMER STATED, SHE FOUND SYRINGES BETWEEN TWO BOXES, MISSING NEEDLES COMPLETELY. STATED, NOTHING WAS STUCK INSIDE THE SHIELD THAT COVERS THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600910 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 SEE H.10 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1