BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 27GA 1/2IN

    MDR report key: 8663692 · Received June 3, 2019

    Report

    Report Number
    3002682307-2019-00341
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 180213, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31 AND DEVICE MANUFACTURE DATE: 2018-02-05. INVESTIGATION SUMMARY: BD HAS REVIEWED 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 2101 (FEBRUARY 09-12ND, 2018) DURING WHICH 63 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES WERE ASSEMBLED NEEDLES IN MACHINE 4412 AND COME FROM 2 BATCHES: -#8029618: (FEBRUARY 09-12ND, 2018) DURING WHICH 177 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. -#8009942: (JANUARY 17-18TH, 2018) DURING WHICH 27 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. CANNULA BATCHES #8071800. INVESTIGATION CONCLUSION: SINCE BD WAS UNABLE TO DUPLICATE OR REPRODUCE INDICATED FAILURE MODE BECAUSE NO SAMPLE HAS BEEN PROVIDING 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. CONSIDERING AVAILABLE INFORMATION, BD BELIEVES A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE RESULTING IN A LEAKAGE. BASED ON OUR EXPERIENCE, THIS ISSUE COULD BE POSSIBLE BECAUSE OF A DEFECTIVE CONNECTIVITY DUE TO 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, AND OUR SAMPLING INSPECTION PLAN. ROOT CAUSE DESCRIPTION: NOT POSSIBLE TO DETERMINE. RATIONALE: SINCE COMPLAINT IS NOT POSSIBLE TO CONFIRM, DHR SHOW NO ABNORMALITIES OR ISSUES AND NO COMPLAINTS FROM OTHER CUSTOMERS, IT WAS DETERMINE THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT FIGHT TIGHTLY ON THE SYRINGE AND MEDICATION LEAKED WITH A BD NEEDLE 27GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3) THE NEEDLE THAT WAS IN THE PACK DID NOT FIT TIGHTLY ON THE SYRINGE (ALTHOUGH THE PHYSICIAN HAD FIXED IT FIRMLY ) AND PART OF THE MEDICATION LEAKED OUT AT THE CONNECTION POINT. THE PHYSICIAN USED ANOTHER NEEDLE AND WAS ABLE TO ADMINISTER THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (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 THE NEEDLE DID NOT FIGHT TIGHTLY ON THE SYRINGE AND MEDICATION LEAKED WITH A BD NEEDLE 27GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3). THE NEEDLE THAT WAS IN THE PACK DID NOT FIT TIGHTLY ON THE SYRINGE (ALTHOUGH THE PHYSICIAN HAD FIXED IT FIRMLY ) AND PART OF THE MEDICATION LEAKED OUT AT THE CONNECTION POINT. THE PHYSICIAN USED ANOTHER NEEDLE AND WAS ABLE TO ADMINISTER THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458443 BD NEEDLE 27GA 1/2IN NEEDLE WITH SYRINGE FMI BECTON DICKINSON, S.A. 180213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other