BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 8MM 10 BAG 500

    MDR report key: 9376798 · Received November 26, 2019

    Report

    Report Number
    1920898-2019-01337
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 8, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) 31GX8MM, 0.5ML RELION INSULIN SYRINGE IN AN OPENED POLYBAG FROM LOT 9070565. CONSUMER REPORTED WHEN HE REMOVED THE NEEDLE SHIELD THE NEEDLE REMAINED IN THE SHIELD. HE DOES NOT KNOW IF THE HUB REMAINED IN THE NEEDLE SHIELD. THE RETURNED SYRINGE WAS EXAMINED, AND NO EVIDENCE OF NEEDLE-HUB/SHIELD ASSEMBLY SEPARATION WAS OBSERVED. SINCE NO MANUFACTURING DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070565. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200812808, 200812871] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200813047] NOTED FOR CRACKED HUBS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 0.5ML 31GA 8MM 10 BAG 500 HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE AND HUB ASSEMBLY REMAINED IN NEEDLE SHIELD WHEN IT WAS REMOVED FROM SYRINGE. VERBATIM: ISSUE: CONSUMER REPORTED WHEN HE REMOVED THE NEEDLE SHIELD THE NEEDLE REMAINED IN THE SHIELD. HE DOES NOT KNOW IF THE HUB REMAINED IN THE NEEDLE SHIELD. HE USES THE 1/2ML, 31G 8MM. SAMPLE AVAILABLE. INCIDENT DATE: (B)(6) 2019. OCCURED-1. ITEM#328509. LOT# 9070565. HE USES THE NEW SYRINGES EACH TIME.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 0.5ML 31GA 8MM 10 BAG 500 HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE AND HUB ASSEMBLY REMAINED IN NEEDLE SHIELD WHEN IT WAS REMOVED FROM SYRINGE. VERBATIM: ISSUE: CONSUMER REPORTED WHEN HE REMOVED THE NEEDLE SHIELD THE NEEDLE REMAINED IN THE SHIELD. HE DOES NOT KNOW IF THE HUB REMAINED IN THE NEEDLE SHIELD. HE USES THE 1/2ML, 31G 8MM. SAMPLE AVAILABLE. INCIDENT DATE: (B)(6) 2019, OCCURED: 1, ITEM# 328509, LOT# 9070565. HE USES THE NEW SYRINGES EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174960 BD SYRINGE 0.5ML 31GA 8MM 10 BAG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9070565 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other