BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 1ML SYRINGE WITH 27G X 1/2" NEEDLE

    MDR report key: 6507843 · Received April 20, 2017

    Report

    Report Number
    3003916417-2017-00004
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 26, 2017
    Report Date
    April 18, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: A SAMPLE IS NOT AVAILABLE, HOWEVER, THE CUSTOMER PROVIDED A PHOTO OF THE AFFECTED DEVICE FOR EVALUATION. A PHOTO INSPECTION REVEALED A NEEDLE THROUGH ITS SAFETY CAP. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6071101. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT HAS BEEN DETERMINED TO BE A MANUFACTURING DEFICIENCY. THE DEFECT OCCURRED BY THE INCOMPLETE COUPLING OF THE NEEDLE AND SAFETY CAP, AFTER THE AIR BLOWING PROCESS, WHICH PROVIDED NON-COMPLIANCE DURING THE PROCESS OF SECURING THE PROTECTIVE CAP. BASED ON THE SEVERITY AND FREQUENCY OF THIS DEFECT, IT HAS BEEN DETERMINED THAT A CAPA IS NOT REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER WAS STUCK WITH THE NEEDLE OF A BD PLASTIPAK¿ 1ML SYRINGE WITH 27G X 1/2" NEEDLE BEFORE PATIENT USE BECAUSE THE NEEDLE HAD PUNCTURED ITS SAFETY CAP. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288410 BD PLASTIPAK¿ 1ML SYRINGE WITH 27G X 1/2" NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 6071101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other