BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8492709 · Received April 8, 2019

    Report

    Report Number
    1911916-2019-00359
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 1, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FIVE (5) SAMPLES WERE RECEIVED AT BD ON 17-APR-2019 FOR INVESTIGATION IN UNOPENED BLISTER PACKS. VISUAL INSPECTION WAS PERFORMED USING 10X MAGNIFICATION. THE SAMPLES ARE NOT BENT AND NO DEFECTS WERE OBSERVED. THERE WAS NO DAMAGE; THE BEVELS AND ETCH WERE GOOD. ADDITIONALLY, NO DEFECTIVE GRIND OR HOOKS WERE NOTED. BASED ON THE INVESTIGATION CONCLUSION, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD¿ BLUNT FILL NEEDLE THE NEEDLE WAS TOO BLUNT AND BROKE WHILE TRYING TO PUNCTURE THE RUBBER VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER MATERIAL NO: 305180; BATCH NO: 8173882. THERE HAS BEEN A LOT OF PRODUCT CONCERNS LATELY REGARDING THE BLUNT FILL NEEDLE 18G VMID 305180. IN MANY INSTANCES, THE NEEDLE WAS TOO BLUNT AND IT BROKE WHILE TRYING TO PUNCTURE THE RUBBER OF A VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD¿ BLUNT FILL NEEDLE THE NEEDLE WAS TOO BLUNT AND BROKE WHILE TRYING TO PUNCTURE THE RUBBER VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER MATERIAL NO: 305180 BATCH NO: 8173882 THERE HAS BEEN A LOT OF PRODUCT CONCERNS LATELY REGARDING THE BLUNT FILL NEEDLE 18G VMID 305180. IN MANY INSTANCES, THE NEEDLE WAS TOO BLUNT AND IT BROKE WHILE TRYING TO PUNCTURE THE RUBBER OF A VIAL.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ BLUNT FILL NEEDLE THE NEEDLE WAS TOO BLUNT AND BROKE WHILE TRYING TO PUNCTURE THE RUBBER VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305180, BATCH NO: 8173882. THERE HAS BEEN A LOT OF PRODUCT CONCERNS LATELY REGARDING THE BLUNT FILL NEEDLE 18G VMID 305180. IN MANY INSTANCES, THE NEEDLE WAS TOO BLUNT AND IT BROKE WHILE TRYING TO PUNCTURE THE RUBBER OF A VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283224 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173882 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other