BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML SYRINGE LUER-LOK TIP W/TIP SHIELD BULK NON-STERILE

    MDR report key: 8704071 · Received June 17, 2019

    Report

    Report Number
    1213809-2019-00626
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 434 LOOSE 3ML SYRINGES WERE RECEIVED AND VISUALLY EVALUATED. 14 SYRINGES WERE OBSERVED TO HAVE NO PRINT DEFECTS, WHILE 420 SYRINGES WERE OBSERVED TO HAVE MISSING PRINT DEFECT. THE MISSING PRINT DEFECT OBSERVED WAS FOUND TO BE A SCUFF MARK IN THE VICINITY OF ¿BD¿ LOGO AND ¿3 ML¿ MARKING. THE SCUFF MARK WAS AT THE SAME VERTICAL LOCATION BUT VARIED LATERALLY FROM BARREL TO BARREL WITH DIFFERENT PARTS OF THE LOGO OR 3ML MARKING MISSING. THE AMOUNT OF MISSING PRINT OBSERVED WAS REJECTABLE PER PRODUCT SPECIFICATION. MACHINE LOGS INDICATE BARREL JAM WAS IDENTIFIED AT THE ASSEMBLY MACHINE AND REQUIRED OPERATOR INTERVENTION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS AND IS LIKELY DUE TO A JAMMED PIECE IN THE ASSEMBLY MACHINE THAT AFFECTED A NUMBER OF BARRELS THAT MOVED PASSED IT. THE DEFECT WOULD HAVE BEEN CREATED IN THE SAME LOCATION VERTICALLY ON THE BARRELS THAT WERE AFFECTED. CORRECTIONS TOOK PLACE AT THE TIME THE ISSUE WAS FOUND DURING THE MANUFACTURE OF THIS BATCH. IT IS LIKELY THE DEFECTIVE PRODUCT WAS NOT COMPLETELY CONTAINED AND GOT MIXED IN WITH THE GOOD PRODUCT. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 3 ML SYRINGE LUER-LOK TIP W/TIP SHIELD BULK NON-STERILE EXPERIENCED SCALE MARKING ISSUES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301073 BATCH NO. 9031771. WE HAVE AN NCMR FOR SYRINGES WITH INCOMPLETE AND ILLEGIBLE INFORMATION: PART NUMBER: 301073 BD SYRINGE, 3ML. LOT NUMBER: 9031771. QUANTITY: 7,079 PIECES. WE WILL APPRECIATE YOUR PROMPT REPLY. EMAIL RECVD BY CUSTOMER (B)(6): ANSWERING YOUR QUESTIONS: THE DATE IT WAS DISCOVERED IS (B)(6) 2019. THERE WERE FOUND 357 PIECES AS RAW MATERIAL AND MORE MATERIAL ALREADY ASSEMBLED WITH THE SAME DEFECT I STILL HAVE THE 357 SAMPLES.

    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 AN UNSPECIFIED NUMBER OF 3 ML SYRINGE LUER-LOK TIP W/TIP SHIELD BULK NON-STERILE EXPERIENCED SCALE MARKING ISSUES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301073, BATCH NO. 9031771. WE HAVE AN NCMR FOR SYRINGES WITH INCOMPLETE AND ILLEGIBLE INFORMATION: PART NUMBER: 301073, BD SYRINGE, 3ML, LOT NUMBER: 9031771. QUANTITY: 7,079 PIECES. WE WILL APPRECIATE YOUR PROMPT REPLY. EMAIL RECEIVED BY CUSTOMER 5/31: ANSWERING YOUR QUESTIONS: THE DATE IT WAS DISCOVERED IS (B)(6) 2019 THERE WERE FOUND 357 PIECES AS RAW MATERIAL AND MORE MATERIAL ALREADY ASSEMBLED WITH THE SAME DEFECT I STILL HAVE THE 357 SAMPLES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497098 3 ML SYRINGE LUER-LOK TIP W/TIP SHIELD BULK NON-STERILE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9031771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other