BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10861496 · Received November 18, 2020

    Report

    Report Number
    1920898-2020-01586
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 17, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 12/4/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (4) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0041282. CUSTOMER STATES THAT THE COVER OVER THE NEEDLE IS TOO TIGHT AND THAT WHEN PULLING THE COVER OFF, THE WHOLE NEEDLE PART COMES OFF. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL WHICH INDICATES THAT THE SHIELD IS DIFFICULT TO REMOVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0041282 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE ORANGE PROTECTIVE COVER OVER THE NEEDLE IS ON TOO TIGHT ON SOME OF HIS SYRINGES. STATED WHEN PULLING THE COVER OFF THE WHOLE NEEDLE PART COMES OFF AND GOES INTO THE CAP. STATED HE HAD 3 SYRINGES IN THE PAST WEEK WITH THESE ISSUES. STATED THIS MAINLY HAPPENED WITH HIS PREVIOUS BOX BUT BELIEVES HE HAD THIS ISSUE WITH ONE SYRINGE FROM THIS CURRENT BOX. DISCARDED PREVIOUS BOX, NO INFORMATION PROVIDED. LOT # 0041282. CAT # 324909.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0041282, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-02-10. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE ORANGE PROTECTIVE COVER OVER THE NEEDLE IS ON TOO TIGHT ON SOME OF HIS SYRINGES. STATED WHEN PULLING THE COVER OFF THE WHOLE NEEDLE PART COMES OFF AND GOES INTO THE CAP. STATED HE HAD 3 SYRINGES IN THE PAST WEEK WITH THESE ISSUES. STATED THIS MAINLY HAPPENED WITH HIS PREVIOUS BOX BUT BELIEVES HE HAD THIS ISSUE WITH ONE SYRINGE FROM THIS CURRENT BOX. DISCARDED PREVIOUS BOX, NO INFORMATION PROVIDED. LOT # 0041282, CAT # 324909, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330626 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 SEE H10 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1