BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 HYPODERMIC NEEDLE

    MDR report key: 8155937 · Received December 12, 2018

    Report

    Report Number
    3002682307-2018-00304
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 23, 2018
    Report Date
    January 15, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR INVESTIGATION. COMPLAINT TRENDING REVIEW REVEALS THIS IS THE FIRST COMPLAINT FOR THIS LOT FOR THIS DEFECT. DHR REVIEW SHOWS OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE 2104 (B)(6) 2017) DURING WHICH 68 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLE WERE ASSEMBLED IN MACHINE 4411 AND COME FROM TWO BATCHES: #7310580: (B)(6) 2017) 285 VISUAL INSPECTION OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. #7186359: (B)(6) 2017) 76 VISUAL INSPECTION OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. RESEARCH HAS NOT FOUND ANY ABNORMALITY IN INJECTED HUB BATCHES #7187497 AND #7193229 (MOLD MACHINE #3583, (B)(6)2017). 3 QN (#10159, #9502 AND #9635) RELATED TO FLASHES WERE REACHED IN INJECTED HUB BATCHES #7297691, #728245 AND #9635, RESPECTIVELY; 4 QN (B)(4) RELATED TO BURNT RESIN WAS REACHED IN INJECTED HUB BATCHES #728245, #7296015, #7251011 AND #7269096; 1 QN (B)(4) RELATED TO CHIPPED PIN IN INJECTED HUB BATCH #7282445, BUT THESE WOULD AFFECT WHETHER OR NOT THE REPORTED CONNECTION PROBLEM. ROOT CAUSE DESCRIPTION: SINCE BD WAS UNABLE TO DUPLICATE YOUR INDICATED FAILURE MODE BECAUSE NO SAMPLE OR PICTURES HAS BEEN PROVIDED AND REVIEW OF DHR SHOW NO ABNORMALITIES DURING NEEDLES MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED NEEDLE MANUFACTURING PROCESS IS NOT POSSIBLE TO DETERMINE, AT THIS TIME. THE DEFECTIVE CONNECTIVITY MAY BE BECAUSE OF A DEFECTIVE LUER DIMENSIONS OR ANY DAMAGE IN THE SYRINGE TIP, BUT IT COULD BE ALSO RELATED WITH THE HANDLING OF THE PRODUCT AS SOME INSUFFICIENT ADJUSTMENT BETWEEN OF THE DEVICES BY THE END USER. ON THE OTHER HAND, BD IS CERTAIN THAT THE PROBABILITY OF HAVING SOME DAMAGED NEEDLE CAUSING DETACHED IN OUR PRODUCT IS VERY LOW BASED ON THE PREVENTIVE MEASURES, ABSENCE OF COMPLAINTS OF OTHER CUSTOMERS AND OUR SAMPLING INSPECTION PLAN. RATIONALE: SINCE COMPLAINT IS NOT POSSIBLE TO CONFIRM BECAUSE NO SAMPLE OR PICTURE HAS BEEN PROVIDED AND REVIEW OF DHR REVEAL NO ABNORMALITIES AND IN COMPLIANCE WITH SPECIFICATION, IT WAS DETERMINE THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD MICROLANCE¿ 3 HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH CONNECTING THE MICROLANCE. THE CONNECTION PROBLEM CAUSED LEAKS DURING THE PROCEDURES AND REQUIRED CHANGING THE UNIT THREE TIMES.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BEFORE USE OF THE BD MICROLANCE¿ 3 HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH CONNECTING THE MICROLANCE. THE CONNECTION PROBLEM CAUSED LEAKS DURING THE PROCEDURES AND REQUIRED CHANGING THE UNIT THREE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997608 BD MICROLANCE¿ 3 HYPODERMIC NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 171126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other