BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE

    MDR report key: 8471653 · Received April 1, 2019

    Report

    Report Number
    1213809-2019-00401
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010271
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO BAGS CONTAINING A TOTAL OF 392 LOOSE 5ML SYRINGES WERE RECEIVED AND VISUALLY INSPECTED. IT WAS OBSERVED THERE WAS SURFACE SCRATCHES WHERE THE INK WAS MISSING. THE SCRATCHES WERE CONSISTENTLY BETWEEN THE 2 AND 3ML MARKINGS WITH MISSING PRINT ON THE GRAD LINES AND ON THE RIGHT SIDE OF THE GRAD LINES INTO THE "2". A TOTAL OF 337 WERE FOUND TO HAVE AT LEAST ONE GRAD LINE OR NUMBER MISSING HALF OR MORE AND ARE REJECTABLE PER PRODUCT SPECIFICATION. TWO SYRINGES WERE FOUND REJECTABLE FOR SIGNIFICANT FLANGE DAMAGE. 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. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT AND DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE HAD SCALE MARKING ERROR . THE FOLLOWING WAS REPORTED, " MATERIAL NO. 301027 BATCH NO. 8231850. IT WAS REPORTED THAT THERE WAS 200+ DEFECTIVE PRODUCTS WITH SCALE MARKING ISSUES. CALL: OUR INSPECTOR DISCOVERED 238 DEFECTIVE PRODUCTS FROM THE SAME BATCH NUMBER (8231850). WOULD YOU LIKE US TO RETURN ADDITIONAL SAMPLES FOR THE INVESTIGATION?"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE HAD SCALE MARKING ERROR. THE FOLLOWING WAS REPORTED, "MATERIAL NO. 301027, BATCH NO. 8231850. IT WAS REPORTED THAT THERE WAS 200+ DEFECTIVE PRODUCTS WITH SCALE MARKING ISSUES. CALL: OUR INSPECTOR DISCOVERED 238 DEFECTIVE PRODUCTS FROM THE SAME BATCH NUMBER (8231850). WOULD YOU LIKE US TO RETURN ADDITIONAL SAMPLES FOR THE INVESTIGATION?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261495 BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8231850 00382903010271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other