BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP

    MDR report key: 7359269 · Received March 21, 2018

    Report

    Report Number
    2243072-2018-00165
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 16, 2018
    Report Date
    May 4, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBER: MEDICAL DEVICE LOT #: 6180546. MEDICAL DEVICE EXPIRATION DATE: 8/31/2021. DEVICE MANUFACTURE DATE: 6/28/2016. INVESTIGATION SUMMARY: ONE NEEDLE AND SEVERAL PHOTOS WERE RETURNED. NOTHING COULD BE DETERMINED FROM THE PHOTOS. A VISUAL INSPECTION OF THE RETURNED SAMPLE WAS PERFORMED WITH NO DEFECTS OR ISSUES OBSERVED. THE NEEDLE WAS THEN ATTACHED TO THE SYRINGE FOR FUNCTIONAL TESTING. NO ISSUES WERE OBSERVED DURING TESTING. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THESE BATCHES, NOR FOR THEIR ASSOCIATED ASSEMBLY BATCHES FOR CLOGGED NEEDLES. DHR REVIEW: BATCH 6180546 ¿ ASSEMBLY BATCH 6181728 HAD 156 VISUAL INSPECTIONS PERFORMED ON 7,950 PARTS WITH ZERO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 77 TIMES USING 1,925 PARTS WITH ZERO FAILURES RECORDED. BATCH 6208988 ¿ ASSEMBLY 6209635 HAD 192 VISUAL INSPECTIONS PERFORMED 9,750 PARTS WITH ZERO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 95 TIMES USING 2,375 PARTS WITH ZERO FAILURES RECORDED. INVESTIGATION CONCLUSION: UNCONFIRMED: NOTHING COULD BE DETERMINED FROM THE PHOTOS. NO ISSUES WERE OBSERVED DURING TESTING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. AS (B)(4) IS AN OEM MANUFACTURING SITE. ADDITIONALLY, THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP MALFUNCTIONED AS ¿WHEN COLLECTING DRUG, HCP FELT RESISTANCE AND IT WAS HARD TO DRAW.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200944 BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP FILTER NEEDLE GAA BECTON DICKINSON 6208988 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other