BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11758797 · Received May 2, 2021

    Report

    Report Number
    1920898-2021-00502
    Event Type
    Malfunction
    Date Received
    May 2, 2021
    Date of Event
    April 5, 2021
    Report Date
    July 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-13 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (2) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT THE NEEDLE CAME OFF WITH THE CAP. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED THE HUB ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR OUT OF SPEC SHIELD PULL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE CAME OFF WITH THE CAP AND ONE SYRINGE WAS MISSING THE END OF THE PLUNGER. VERBATIM: EMAIL RECEIVED¿2021-04-05 10:21:32I RECEIVED A BOX OF ONE HUNDRED 3/10 CC\\ML, 8 MM, 31 GAUGE INSULIN SYRINGES CONTAINING SEVERAL DEFECTIVE SYRINGES.SEVERAL SYRINGES HAD NEEDLE CAPS THAT WHEN I REMOVED THEM BY PULLING THE NEEDLE CAP STRAIGHT OFF, THE NEEDLE CAME OFF IN THE CAP AND COULD NOT BE REMOVED. (I DID NOT TWIST OR BEND THE NEEDLE CAP WHEN REMOVING IT) THERE WAS ALSO ONE SYRINGE MISSING THE END OF THE PLUNGER.I HAVE USED BD INSULIN SYRINGES FOR OVER 40 YEARS AND HAVE NEVER HAD DEFECTIVE SYRINGES LIKE THESE LOT # 0090638 B MANUFACTURE DATE 5/1/20EXPIRATION DATE 4/30/25"5.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE CAME OFF WITH THE CAP AND ONE SYRINGE WAS MISSING THE END OF THE PLUNGER. VERBATIM: EMAIL RECEIVED¿2021-04-05 10:21:32I RECEIVED A BOX OF ONE HUNDRED 3/10 CC\\ML, 8 MM, 31 GAUGE INSULIN SYRINGES CONTAINING SEVERAL DEFECTIVE SYRINGES.SEVERAL SYRINGES HAD NEEDLE CAPS THAT WHEN I REMOVED THEM BY PULLING THE NEEDLE CAP STRAIGHT OFF, THE NEEDLE CAME OFF IN THE CAP AND COULD NOT BE REMOVED. (I DID NOT TWIST OR BEND THE NEEDLE CAP WHEN REMOVING IT)THERE WAS ALSO ONE SYRINGE MISSING THE END OF THE PLUNGER.I HAVE USED BD INSULIN SYRINGES FOR OVER 40 YEARS AND HAVE NEVER HAD DEFECTIVE SYRINGES LIKE THESE. LOT # 0090638 B, MANUFACTURE DATE: 5/1/20. EXPIRATION DATE: 4/30/25".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654980 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1