BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML HEPARIN

    MDR report key: 8977641 · Received September 9, 2019

    Report

    Report Number
    1213809-2019-00912
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 20, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NZW
    UDI-DI
    30382903096467
    PMA / PMN Number
    K090680
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHEN CUSTOMER SCANNED PRODUCT IT STATED THE IT WAS AN "EACH" INSTEAD OF "SHELF PACK" WITH A BD SYRINGE 3ML HEPARIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER IS HAVING A CHALLENGE SCANNING PRODUCT 306413. STATES THAT THE PRIMARY DI SHOULD BE THE ¿EACH¿ LEVEL (00382903064137) INSTEAD OF THE SHELF PACK LEVEL (30382903064138). D.1. MEDICAL DEVICE BRAND NAME: BD SYRINGE 3ML HEPARIN. D.1 MEDICAL DEVICE TYPE: NZW. D.2. COMMON DEVICE NAME: HEPARIN, VASCULAR ACCESS FLUSH. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND COMPANY ¿ COLOMBUS, NE / 68601. D.4 MEDICAL DEVICE CATALOG #: 306413. G.2 MANUFACTURING LOCATION: BECTON DICKINSON AND COMPANY ¿ COLOMBUS, NE / 68601. G.5. PMA / 510(K)#: K090680.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CUSTOMER SCANNED PRODUCT IT STATED THE IT WAS AN "EACH" INSTEAD OF "SHELF PACK" WITH A BD SYRINGE 3ML HEPARIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER IS HAVING A CHALLENGE SCANNING PRODUCT 306413. STATES THAT THE PRIMARY DI SHOULD BE THE ¿EACH¿ LEVEL (00382903064137) INSTEAD OF THE SHELF PACK LEVEL (30382903064138).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CUSTOMER SCANNED PRODUCT IT STATED THE IT WAS AN "EACH" INSTEAD OF "SHELF PACK" WITH A BD SYRINGE 3ML HEPARIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER IS HAVING A CHALLENGE SCANNING PRODUCT 306413. STATES THAT THE PRIMARY DI SHOULD BE THE ¿EACH¿ LEVEL (B)(4) INSTEAD OF THE SHELF PACK LEVEL (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CUSTOMER SCANNED PRODUCT IT STATED THE IT WAS AN "EACH" INSTEAD OF "SHELF PACK" WITH A 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771121 BD SYRINGE 3ML HEPARIN HEPARIN, VASCULAR ACCESS FLUSH NZW BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other