BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 9727857 · Received February 19, 2020

    Report

    Report Number
    1213809-2020-00115
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 26, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059004
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A TOTAL OF 12 SEALED PACKAGED SAFETYGLIDE NEEDLES FROM MULTIPLE BATCHES WERE RECEIVED, ALL WERE P/N 305900. 4 PACKAGES WERE FROM THE REPORTED BATCH 8212561, 1 PACKAGE WAS FROM BATCH #8285702, 7 PACKAGES WERE FROM BATCH 9316337. SINCE THE DESCRIBED ALLEGED DEFECT IS NOT APPLICABLE TO THIS PRODUCT, THE SAMPLES COULD NOT BE EVALUATED. IT WAS ALSO UNKNOWN FOR WHAT PURPOSE THE SAMPLES FOR THE TWO ADDITIONAL NON-REPORTED BATCHES WERE SENT. THE DESCRIBED ALLEGED DEFECT OF ISSUES WITH A ¿RETRACTABLE SPRING¿ AND NEEDLE ¿NOT RETRACTING AT ALL¿ ARE NOT APPLICABLE TO THIS PRODUCT. THE SAFETYGLIDE NEEDLE PRODUCT DOES NOT HAVE A RETRACTABLE SPRING AND THE NEEDLE IN THIS PRODUCT DOES NOT RETRACT PER SPECIFICATION. SINCE NO CLARIFICATION WAS RECEIVED REGARDING THE ALLEGED FAILURE, NO INVESTIGATION CAN BE PERFORMED ON THE RETURNED SAMPLES. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT AND MEDICATION LEAKED OUT OF NEEDLE DURING USE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE RETRACTABLE SPRING DOES NOT RETRACT. IT WAS ALSO REPORTED THAT MEDICATION LEAKED OUT OF THE NEEDLE. PATIENT WAS INVOLVED BUT NO HARM OR ADVERSE EFFECTS.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. 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 RETRACT AND MEDICATION LEAKED OUT OF NEEDLE DURING USE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE RETRACTABLE SPRING DOES NOT RETRACT. IT WAS ALSO REPORTED THAT MEDICATION LEAKED OUT OF THE NEEDLE. PATIENT WAS INVOLVED BUT NO HARM OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194006 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305900 8212561 30382903059004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other