BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 8470268 · Received April 1, 2019

    Report

    Report Number
    1911916-2019-00330
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 30, 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: 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 18X1-1/2 BLUNT FILL EXPERIENCED CANNULA BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO: 305180 BATCH NO: 8173882. IT WAS REPORTED THAT NEEDLE WAS TOO BLUNT AND BROKE WHILE TRYING TO PUNCTURE THE RUBBER VILE. PER CUSTOMER EMAIL: 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. I HAVE NOT BEEN ABLE TO IDENTIFY IF IT IS COMING FROM A SINGLE BATCH, BUT THE PRODUCT CONCERNS ARE COMING MOSTLY FROM IHA AND AT THE TIME, IHA MENTIONED LOT# 8173882.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 18X1-1/2 BLUNT FILL EXPERIENCED CANNULA BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO: 305180 BATCH NO: 8173882 IT WAS REPORTED THAT NEEDLE WAS TOO BLUNT AND BROKE WHILE TRYING TO PUNCTURE THE RUBBER VILE. PER CUSTOMER EMAIL: 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. I HAVE NOT BEEN ABLE TO IDENTIFY IF IT IS COMING FROM A SINGLE BATCH, BUT THE PRODUCT CONCERNS ARE COMING MOSTLY FROM IHA AND AT THE TIME, IHA MENTIONED LOT# 8173882.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 18X1-1/2 BLUNT FILL EXPERIENCED CANNULA BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO: 305180, BATCH NO: 8173882. IT WAS REPORTED THAT NEEDLE WAS TOO BLUNT AND BROKE WHILE TRYING TO PUNCTURE THE RUBBER VILE. PER CUSTOMER EMAIL: 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. I HAVE NOT BEEN ABLE TO IDENTIFY IF IT IS COMING FROM A SINGLE BATCH, BUT THE PRODUCT CONCERNS ARE COMING MOSTLY FROM (B)(6) AND AT THE TIME, (B)(6) MENTIONED LOT# 8173882.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265111 NEEDLE 18X1-1/2 BLUNT FILL MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173882 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other