BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8895063 · Received August 14, 2019

    Report

    Report Number
    1920898-2019-00806
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 28, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER PROVIDED ONE (1) PHOTO OF A 0.3ML BD INSULIN SYRINGE. NO SAMPLES WERE RETURNED AS OF 28 AUGUST 2019. CONSUMER REPORTED ¿AS I ATTEMPTED TO REMOVE THE ORANGE NEEDLE CAP, THE ENTIRE NEEDLE CAME OFF OF THE SYRINGE¿. THE PHOTO PROVIDED BY THE CUSTOMER WAS REVIEWED, AND IT WAS OBSERVED THAT THE NEEDLE-HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. THE CAUSE OF THE NEEDLE-HUB SEPARATION LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8337703. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR CRACKED HUBS BASED ON THE PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1143044, "ON 28 AUG 2019, HOLDREGE RECEIVED A PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO SHOWS (1) SYRINGE WITH NO NEEDLE ASSEMBLY ATTACHED TO IT. THE NEEDLE ASSEMBLY WAS SEPARATE FROM THE SYRINGE. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIPS OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY CORE PIN DAMAGE ON THE HUB. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: THE NEEDLE ASSEMBLY PRESS STATION WAS OUT OF ADJUSTMENT. ZM200794547 WAS CREATED ON 25 JAN 2019 CORRECTIVE ACTION: NEEDLE ASSEMBLY PRESS STATION WAS ADJUSTED. L2L DISPATCH #52820 WAS CREATED ON 25 JAN 2019 TO ADJUST THE PRESS STATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. TIP-2019-37 WAS IMPLEMENTED ON 10JUL2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA1122103 WAS BEEN OPENED ON 16 AUG 2019 TO ADDRESS THIS ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB IS SEPARATING FROM THE DEVICE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM 3 SYRINGES. AS I ATTEMPTED TO REMOVE THE ORANGE NEEDLE CAP, THE ENTIRE NEEDLE CAME OFF OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT THE NEEDLE HUB IS SEPARATING FROM THE DEVICE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM 3 SYRINGES. AS I ATTEMPTED TO REMOVE THE ORANGE NEEDLE CAP, THE ENTIRE NEEDLE CAME OFF OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685507 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8337703 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other