BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE

    MDR report key: 14017861 · Received April 5, 2022

    Report

    Report Number
    1920898-2022-00223
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 16, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    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

    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 INVESTIATION WAS UPDATED DUE TO ADDITIONAL INFORMATION: H6: INVESTIGATION SUMMARY AS PER REQUEST, SAMPLES WERE FORWARDED TO HOLDREGE ON 10-MAY-2022 FOR FURTHER REVIEW. HOLDREGE MEASURED THE SAMPLES AND ADDITIONALLY FOUND THAT 7 OUT OF 146 SAMPLES IN THE SHELF CARTON WERE 31GX8MM. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242322. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THIS NEW INFORMATION, THE INVESTIGATION IS NOW CONCLUDED AS: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 31-MAR-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 4 SYRINGES ALONGSIDE A SHELF CARTON OF 0.5ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 1242322. THE NEEDLES OF THE 4 SYRINGES WERE MEASURED AND ALL WERE FOUND TO BE APPROXIMATELY 7.5MM- 7.7MM IN LENGTH, WHICH ARE WITHIN SPEC FOR 8MM SYRINGES, BUT OUT OF SPEC FOR 12.7MM SYRINGES. SOME 8MM SYRINGES APPEAR TO HAVE BEEN MIXED WITH THIS GROUP OF 12.7MM SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242322. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SEVERAL SYRINGE NEEDLES BEING SHORTER THAN THEY WERE LABELED FOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS FOUND TO BE SHORTER IN FOUR BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: 326666 LDS 12.7 MM WITH MIXED SHORT NEEDLES. I REMOVED THE NEEDLE CAP AND FOUND FOUR SHORT NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS FOUND TO BE SHORTER IN FOUR BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: 326666 LDS 12.7 MM WITH MIXED SHORT NEEDLES. I REMOVED THE NEEDLE CAP AND FOUND FOUR SHORT NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS FOUND TO BE SHORTER IN FOUR BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: 326666 LDS 12.7 MM WITH MIXED SHORT NEEDLES. I REMOVED THE NEEDLE CAP AND FOUND FOUR SHORT NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813008 BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown