BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16812579 · Received April 25, 2023

    Report

    Report Number
    1920898-2023-00258
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 4, 2023
    Report Date
    July 27, 2023
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 09-JUN-2023. H6: INVESTIGATION SUMMARY THE CUSTOMER RETURNED (3) 0.3ML, 30GA 8MM SYRINGES, REPORTING INCORRECT STOPPER PLACEMENT. THE SAMPLES WERE VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED. A FUNCTIONALITY TEST WAS PERFORMED AND NO PRODUCT DEFICIENCIES RELATED TO STOPPER INCORRECT PLACEMENT WERE OBSERVED. BASED ON THE RETURNED SAMPLES, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2031535. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. ROOT CAUSE CANNOT BE DETERMINED AS THE REPORTED FAILURE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2031535. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

    H3. 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 2 OF THE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE STOPPER DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE USER'S REPORT, THE STOPPER USUASLLY STOPPED AT THE SCALE 3, BUT THOSE TWO SYRINGES REACHED THE TIP OF PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE STOPPER DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE USER'S REPORT, THE STOPPER USUASLLY STOPPED AT THE SCALE 3, BUT THOSE TWO SYRINGES REACHED THE TIP OF PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE STOPPER DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE USER'S REPORT, THE STOPPER USUALLY STOPPED AT THE SCALE 3, BUT THOSE TWO SYRINGES REACHED THE TIP OF PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668599 BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2031535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown