BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES 3/10ML 6MM (15/64") 31G U-100

    MDR report key: 17295367 · Received July 10, 2023

    Report

    Report Number
    1920898-2023-00433
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 19, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1109192; D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026; H.4. DEVICE MANUFACTURE DATE: 19-APR-2021; D.4. MEDICAL DEVICE LOT #: 1326350; D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026; H.4. DEVICE MANUFACTURE DATE: 22-NOV-2021; D.4. MEDICAL DEVICE LOT #: 2066145; D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027; H.4. DEVICE MANUFACTURE DATE: 07-MAR-2022; D.4. MEDICAL DEVICE LOT #: 2220410; D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027; H.4. DEVICE MANUFACTURE DATE: 08-AUG-2022. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 14-JUL-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 0.3ML 31G 6MM SYRINGES FROM THE LOT# 2220410. IT WAS REPORTED BY THE CUSTOMER THAT THERE APPEARS TO BE A GAP BETWEEN SYRINGE HEAD AND SYRINGE BODY THAT LEADS TO SYRINGE HEAD LOOKING BENT. THE RETURNED SAMPLE VISUALLY EXAMINED AND OBSERVED A GAP BETWEEN CANNULA HUB AND BARREL, LEADING TO BENT CANNULA HUB (SYRINGE BOWED). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE RETURN SAMPLES, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. NO ROOT CAUSE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD INSULIN SYRINGES 3/10ML 6MM THE SYRINGE IS DAMAGED AND APPEARS BENT. 1 OF 2 REPORTED DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE PURCHASED 324919 SYRINGES FROM MULTIPLE LOTS AND APPROXIMATELY SINCE APRIL 2022 WE STARTED SEEING DEFECTIVE SYRINGES IN EACH LOT WE RECEIVED. ...SYRINGE BODY THAT LEADS TO SYRINGE HEAD LOOKING BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD INSULIN SYRINGES 3/10ML 6MM THE SYRINGE IS DAMAGED AND APPEARS BENT. 1 OF 2 REPORTED DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE PURCHASED 324919 SYRINGES FROM MULTIPLE LOTS AND APPROXIMATELY SINCE APRIL 2022 WE STARTED SEEING DEFECTIVE SYRINGES IN EACH LOT WE RECEIVED. ...SYRINGE BODY THAT LEADS TO SYRINGE HEAD LOOKING BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312288 BD INSULIN SYRINGES 3/10ML 6MM (15/64") 31G U-100 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown