BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8795507 · Received July 16, 2019

    Report

    Report Number
    1213809-2019-00746
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 5, 2019
    Report Date
    August 20, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR PHOTOS OF LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL THE SYRINGES IN THE PHOTOS WERE MISSING PRINT AT THE 3ML GRAD LINE. THREE OF THE PHOTOS SHOWED THE ¿3¿ SCRATCHED MOSTLY OR COMPLETE OFF AND ONE PHOTO SHOWED THE ¿M¿ FROM ¿ML¿ SCRATCHED OFF. ALL THE PRINT DEFECTS IN THE PHOTOS ARE REJECTABLE PER PRODUCT SPECIFICATION. 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. 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. THE ISSUE IS CONSIDERED ISOLATED. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9031771 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE SECTION 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/MISSING/ILLEGIBLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301073 BATCH NO. 9031771 INCIDENT DESCRIPTION: PRODUCTION AREA REPORTED MISPRINTING IN THE SCALE OF SYRINGE FOR THE PART NUMBER 70072231, LOT 9031771. IN SOME SYRINGE THE WORDS "ML" AND THE NUMBER "3" ARE MISPRINTING OR MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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/MISSING/ILLEGIBLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301073, BATCH NO. 9031771. INCIDENT DESCRIPTION: PRODUCTION AREA REPORTED MISPRINTING IN THE SCALE OF SYRINGE FOR THE PART NUMBER 70072231, LOT 9031771. IN SOME SYRINGE THE WORDS "ML" AND THE NUMBER "3" ARE MISPRINTING OR MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590322 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