BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1213809-2018-00780

    MDR report key: 8079511 · Received November 16, 2018

    Report

    Report Number
    1213809-2018-00780
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 29, 2018
    Report Date
    December 5, 2018
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DEPICTS OUTSIDE OF ONE SIDE OF A SHELF CARTON. A LABEL ON THE CARTON CONFIRMS THE CARTON BELONGS TO SAFETYGLIDE NEEDLE PRODUCT FROM BATCH #7212773 (P/N 305917). NO PRODUCT ITSELF CAN BE SEEN IN THE PHOTO. 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 A DIFFERENT LENGTH, PINK-CAPPED NEEDLE WAS PACKAGED AND LABELED AS A GREEN-CAPPED BD SAFETYGLIDE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 A DIFFERENT LENGTH, PINK-CAPPED NEEDLE WAS PACKAGED AND LABELED AS A GREEN-CAPPED BD SAFETYGLIDE¿ NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other