BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17295362 · Received July 10, 2023

    Report

    Report Number
    1920898-2023-00432
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 14-JUL-2023 H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    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.

    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 RESULTING IN COMPONENT SEPARATION. 2 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. ... WE SAW SYRINGE HEADS FALL OFF DURING NORMAL USE IN EXTREME CASES OF THE "HEAD GAP" DEFECT.

    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 RESULTING IN COMPONENT SEPARATION. 2 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. ... WE SAW SYRINGE HEADS FALL OFF DURING NORMAL USE IN EXTREME CASES OF THE "HEAD GAP" DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312283 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