BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11729206 · Received April 26, 2021

    Report

    Report Number
    1920898-2021-00465
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    January 21, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED; THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. THE REPORTED ISSUE WAS OBSERVED AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. CORRECTIVE/PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR CANNULA MISSING ON LOT # 0020542. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF 1 LOOSE 0.3ML BD INSULIN SYRINGE WAS PROVIDED. THE CUSTOMER REPORTED THAT THE SYRINGE CAME WITHOUT A NEEDLE. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS NOT ATTACHED TO THE BARREL. THE SEPARATED HUB ASSEMBLY WAS NOT SHOWN IN THE PHOTO PROVIDED, AND NO DAMAGE TO THE BARREL TIP WAS OBSERVED. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THE OBSERVED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020542. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES WERE RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED (HUB SEPARATES) AS PER MANUFACTURING: CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT CONTACTED US VIA EMAIL REGARDING A QUALITY DEVIATION IN THE BD ULTRA-FINE 6MM SYRINGES CAPACITY 30UI LOT 0020542. REPORTED THAT HE USES THE BD SYRINGES SHORTLY AND EVERY LOT HE BUYS ONE OR TWO SYRINGES COMES WITHOUT A NEEDLE, BUT HE ONLY KNEW THE LAST LOT HE ACQUIRED IN WHICH HE PRESENTED 2 SYRINGES WITHOUT A NEEDLE, WE QUESTIONED IF HE REALIZED IF THE NEEDLE WAS STUCK IN THE ORANGE PROTECTIVE COVER, PATIENT MENTIONED THAT IT REALLY CAME WITHOUT A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622090 BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 0020542

    Patients

    Seq Age Sex Outcome Treatment
    1