BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE 6MM¿ INSULIN SYRINGE 0,5ML 31G X 6MM U-100 10X3COUNT

    MDR report key: 15429620 · Received September 15, 2022

    Report

    Report Number
    9614033-2022-00072
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 19, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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, RETURNED TO MANUFACTURER ON: 20-SEP-2022. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 0.5ML BD INSULIN SYRINGE WITH AN OPEN POLYBAG FROM LOT# 2010330, AS WELL AS (6) PHOTOS OF A LOOSE INSULIN SYRINGE. THE CUSTOMER REPORTED THAT THE HUB SEPARATED FROM THE SYRINGE. THE SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS PROPERLY ATTACHED TO THE BARREL; REMOVING THE CANNULA SHIELD FROM THE SYRINGE DID NOT RESULT IN HUB SEPARATION. THE 6 PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS DETACHED FROM THE SYRINGE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2010330. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE 6MM¿ INSULIN SYRINGE 0,5ML 31G X 6MM U-100 10X3COUNT THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE LAST SYRINGE OF POLYBAG WAS GOING TO BE USED, AND THE SHIELD WAS REMOVED, THE USER NOTICED THAT THE HUB SEPARATED FROM THE SYRINGE, SO IT WAS NOT POSSIBLE TO USE THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 22.AUG.2022: THE SHIELD WAS NOT TIGHT, IT CAME OFF EASILY AND WITHOUT EXTRA EFFORT. THE SAMPLE IS STILL PROTECTED AT HOME AND I HAVE ALREADY AGREED TO DELIVER IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE 6MM¿ INSULIN SYRINGE 0,5ML 31G X 6MM U-100 10X3COUNT THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE LAST SYRINGE OF POLYBAG WAS GOING TO BE USED, AND THE SHIELD WAS REMOVED, THE USER NOTICED THAT THE HUB SEPARATED FROM THE SYRINGE, SO IT WAS NOT POSSIBLE TO USE THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 22.AUG.2022: THE SHIELD WAS NOT TIGHT, IT CAME OFF EASILY AND WITHOUT EXTRA EFFORT. THE SAMPLE IS STILL PROTECTED AT HOME AND I HAVE ALREADY AGREED TO DELIVER IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475216 BD ULTRA-FINE 6MM¿ INSULIN SYRINGE 0,5ML 31G X 6MM U-100 10X3COUNT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON DE MEXICO 2010330

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female