BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ 30 G

    MDR report key: 15631746 · Received October 19, 2022

    Report

    Report Number
    1911916-2022-00569
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 12, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE TWO POSSIBLE LOT NUMBERS REPORTED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1075264. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. DEVICE MANUFACTURE DATE: 27-MAR-2021. MEDICAL DEVICE LOT #: 2020895. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. DEVICE MANUFACTURE DATE: 02-APR-2022. FDA NOTIFIED: THE INITIAL REPORTER NOTIFIED THE FDA VIA UF/IMPORTER REPORT#: MW111910 . INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE BROKE OFF FROM HUB. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. BOTH PHOTOS SHOW A NEEDLE ASSEMBLY CONNECTED TO A SYRINGE. THE NEEDLE ASSEMBLY SHOWS THE BOTTOM PART OF THE NEEDLE. THE NEEDLE HUB IS TRANSPARENT AND HELPS TO SEE THE INSIDE OF THE ASSEMBLY. FROM THE PHOTO, IT IS NOT POSSIBLE TO CONFIRM THIS NEEDLE IS A BD NEEDLE ASSEMBLY MATERIAL 305106. MATERIAL 305106 HAS A DIFFERENT COLOR HUB THAN THE NEEDLE HUB SHOWN IN THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, POSSIBLE LOT NUMBERS 2020895 AND 1075264. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE POSSIBLE LOTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ 30 G EXPERIENCED A BROKEN NEEDLE. THE BROKEN PORTION OF THE NEEDLE BECAME EMBEDDED WITHIN THE PATIENT, AND REQUIRED IMAGING TO LOCATE. THE BROKEN NEEDLE PORTION WAS NOT RETRIEVED DURING IMAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER REMOVAL OF LOCAL ANESTHETIC INJECTION, UTILIZING A 30G/ 1.3 MM NEEDLE, IT WAS NOTED THAT NEEDLE BROKE OFF FROM HUB AND REMAINED LODGED IN PATIENT. CAN YOU PLEASE PROVIDE ADDITIONAL DETAILS IN REGARDS TO THE ISSUE? SURGEON WAS PERFORMING A PUDENDAL NERVE BLOCK. AFTER INJECTING THE LOCAL ANESTHETIC, AND REMOVING THE NEEDLE, IT WAS NOTED THAT THE NEEDLE WAS BROKEN OFF FROM THE SYRINGE. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS REPORTED DEFECT? RETAINED NEEDLE. HOW WAS THE NEEDLE REMOVED? THE NEEDLE COULD NOT BE RETRIEVED. WAS AN X-RAY, ULTRASOUND, CT SCAN, OR MRI PERFORMED AND IF SO WHAT WERE THE RESULTS? IMAGING WAS PERFORMED. NEEDLE WAS VISUALIZED, BUT COULD NOT BE RETRIEVED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2945593 BD PRECISIONGLIDE¿ 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 UNKNOWN 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other