BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 11638970 · Received April 8, 2021

    Report

    Report Number
    2243072-2021-01046
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    October 14, 2019
    Report Date
    October 27, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051282
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE CAME OUT OF THE HUB AND LODGED IN THE PATIENT'S FACE. IT WAS REPORTED THAT THE NEEDLE LODGED IN THE PATIENT'S FACE DURING A TRIGGER POINT INJECTION. PER COMPLAINT DETAILS: BD¿S REGISTERED AGENT WAS SERVED WITH THE COMPLAINT FILED IN SANTA CLARA COUNTY IN CALIFORNIA. PLAINTIFF ALLEGES THAT HE SUSTAINED ¿PERMANENT INJURIES AFTER A NEEDLE BECAME LODGED IN [HIS] FACE DURING A TRIGGER POINT INJECTION PROCEDURE ON OR AROUND (B)(6) 2019.¿ THE COMPLAINT DOES NOT IDENTIFY THE BD NEEDLE USED. D1: MEDICAL DEVICE BRAND NAME: BD PRECISIONGLIDE¿ NEEDLE. D4: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. D4: CATALOG #:305128. D4: MEDICAL DEVICE LOT #: 8093756. D4: MEDICAL DEVICE MANUFACTURER: BD MEDICAL (BD WEST) MEDICAL SURGICAL. D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2023. D4: UDI #: (B)(4). G4: MANUFACTURING LOCATION: BD MEDICAL (BD WEST) MEDICAL SURGICAL. G.5. PMA / 510(K)#: K021475. H4: DEVICE MANUFACTURE DATE: 03-APR-2018. H6. INVESTIGATION SUMMARY: IT WAS REPORTED A NEEDLE LODGED IN A PATIENT'S FACE DURING A TRIGGER POINT INJECTION. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A NEEDLE, ABOUT 2.5CM IN LENGTH, NEXT TO A RULER. THE NEEDLE IS STRAIGHT, AND THE BOTTOM PART OF THE NEEDLE IS RED. THE RED AREA IS WHERE THE EPOXY IS APPLIED TO FIX THE NEEDLE TO THE PLASTIC HUB. BD NEEDLES ARE PRODUCED WITH A WHITE, NOT RED, EPOXY. THE TOTAL LENGTH OF THE BD NEEDLE REPORTED IS 1 1/4", NOT 1" OR 2.5CM. THE SAMPLE SHOWN IN THE PHOTOS DO NOT MEET THE BD LENGTH SPECIFICATION, AS WELL AS THE COLOR AND LOCATION OF THE EPOXY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305128, LOT NUMBER 8093756. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE CAME OUT OF THE HUB AND LODGED IN THE PATIENT'S FACE. IT WAS REPORTED THAT THE NEEDLE LODGED IN THE PATIENT'S FACE DURING A TRIGGER POINT INJECTION. PER COMPLAINT DETAILS: BD¿S REGISTERED AGENT WAS SERVED WITH THE COMPLAINT FILED IN SANTA CLARA COUNTY IN CALIFORNIA. PLAINTIFF ALLEGES THAT HE SUSTAINED ¿PERMANENT INJURIES AFTER A NEEDLE BECAME LODGED IN [HIS] FACE DURING A TRIGGER POINT INJECTION PROCEDURE ON OR AROUND OCTOBER 14, 2019.¿ THE COMPLAINT DOES NOT IDENTIFY THE BD NEEDLE USED.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ NEEDLE CAME OUT OF THE HUB AND LODGED IN THE PATIENT'S FACE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE NEEDLE LODGED IN THE PATIENT'S FACE DURING A TRIGGER POINT INJECTION. PER COMPLAINT DETAILS: BD¿S REGISTERED AGENT WAS SERVED WITH THE COMPLAINT FILED IN SANTA CLARA COUNTY IN CALIFORNIA. PLAINTIFF ALLEGES THAT HE SUSTAINED ¿PERMANENT INJURIES AFTER A NEEDLE BECAME LODGED IN [HIS] FACE DURING A TRIGGER POINT INJECTION PROCEDURE ON OR AROUND (B)(6) 2019.¿ THE COMPLAINT DOES NOT IDENTIFY THE BD NEEDLE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529774 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305128 8093756 30382903051282

    Patients

    Seq Age Sex Outcome Treatment
    1 Male