BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE

    MDR report key: 16385688 · Received February 16, 2023

    Report

    Report Number
    1920898-2023-00052
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 23, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266388
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2010740. MEDICAL DEVICE EXPIRATION DATE: 31JAN2027. DEVICE MANUFACTURE DATE:10JAN2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: D4: MEDICAL DEVICE LOT #: 2010740; D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027; H4: DEVICE MANUFACTURE DATE: 10-JAN-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) SYRINGE 0.3ML 30GA 8MM IN A CLEAR POLYBAG AND ONE EMPTY SEAL OPENED PACKAGING POLYBAG. ALL THE SYRINGES WERE VISUALLY EXAMINED AND OBSERVED NO ISSUES. ALL THE SYRINGES WERE INSPECTED VIA GAUGE TO ENSURE CORRECT PLACEMENT OF THE GRADUATION MARKINGS AND OBSERVED ALL THE RETURN SAMPLES FOUND TO BE WITHIN PERMITTED SPECIFICATIONS. HENCE, THE ALLEGED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURN FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2010740 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE THERE WERE SCALE MARKING ISSUES. THIS OCCURRED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE USER REPORTED THAT THE SCALE WAS MISALIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE THERE WERE SCALE MARKING ISSUES. THIS OCCURRED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE USER REPORTED THAT THE SCALE WAS MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656934 BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2010740 00382903266388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown