BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1920898-2018-00830

    MDR report key: 8038987 · Received November 5, 2018

    Report

    Report Number
    1920898-2018-00830
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 7, 2018
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (35) SEALED TRAYS OF 1ML, 13MM, 27G BD ALLERGY SYRINGES FROM CAT # 305540, LOT # 7320520, (3) SEALED TRAYS OF 1ML, 13MM, 27G BD ALLERGY SYRINGES FROM CAT # 305540, LOT # 6351540, (3) SEALED TRAYS OF 1/2ML, 13MM, 27G BD ALLERGY SYRINGES FROM CAT # 305535, LOT # 7076383, AND (1) SEALED TRAY OF 1/2ML, 13MM, 27G BD ALLERGY SYRINGES FROM CAT # 305535, LOT # 7072702. CUSTOMER STATES THAT UPON RECEIPT OF THE TWO CASES OF BD5540 THEY NOTICED BOTH CASES HAD A MIX OF BD5540 AND BD5535 SYRINGES IN THEM. ALL RETURNED TRAYS WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON ANY OF THE TRAYS. A MIX BETWEEN THE DIFFERENT CATALOG NUMBERS AND LOT NUMBERS RETURNED BY THE CUSTOMER WOULD MOST LIKELY NOT OCCUR DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7320520. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200727040] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS MANUFACTURING DEFECT AS THIS WOULD MOST LIKELY NOT OCCUR DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALLERGY SYRINGE TRAY IN BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE CONTAINED MIXED PRODUCT IN THE PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ALLERGY SYRINGE TRAY IN BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE CONTAINED MIXED PRODUCT IN THE PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other