BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 7129573 · Received December 19, 2017

    Report

    Report Number
    1213809-2017-00369
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    February 20, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP NUMBER. THIS IS THE FIRST FOLLOW UP FOR THIS COMPLAINT, BUT IT WAS ELECTRONICALLY REJECTED WHEN DESIGNATED AS FOLLOW UP # 1. IT IS SUBMITTED AS FOLLOW UP 2 IN ORDER TO WORK AROUND THAT REJECTION. INVESTIGATION RESULTS: SAMPLE EVALUATION: FOUR 5ML PACKAGED SYRINGES, TWO SEALED AND 2 IN OPENED PACKAGES, WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH # 7190529 (P/N 309649). THE SAMPLES WERE VISUALLY EVALUATED. ALL FOUR SYRINGES WERE FOUND TO HAVE MISSING PRINT AROUND THE CENTER OF THE SCALE MARKINGS. THE PRINT WAS ALMOST ENTIRELY MISSING. THE 4 SAMPLES COULD BE LINED AS TO SHOW THE AMOUNT OF PRINT TO GROW MORE PRESENT FROM THE CENTER OUT FROM ONE SAMPLE TO NEXT. ALL SAMPLES OBSERVED WERE REJECTABLE PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 7190529 (P/N 309649): MANUFACTURING DATES: 07/10/2017 TO 07/11/2017. BATCH QUANTITY WAS (B)(4). MARKING AND ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. AN INSTANCE OF MISSING PRINT WAS RECORDED DURING MANUFACTURE OF THIS BATCH AND SEVERAL INSTANCES OF MARKER DOWN TIME. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7190529 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SAMPLE EVALUATION: FOUR 5ML PACKAGED SYRINGES, TWO SEALED AND 2 IN OPENED PACKAGES, WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #7190529 (P/N 309649). THE SAMPLES WERE VISUALLY EVALUATED. ALL FOUR SYRINGES WERE FOUND TO HAVE MISSING PRINT AROUND THE CENTER OF THE SCALE MARKINGS. THE PRINT WAS ALMOST ENTIRELY MISSING. THE 4 SAMPLES COULD BE LINED AS TO SHOW THE AMOUNT OF PRINT TO GROW MORE PRESENT FROM THE CENTER OUT FROM ONE SAMPLE TO NEXT. ALL SAMPLES OBSERVED WERE REJECTABLE PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 7190529 (P/N 309649): MANUFACTURING DATES: 07/10/2017 TO 07/11/2017. BATCH QUANTITY WAS (B)(4). MARKING AND ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. AN INSTANCE OF MISSING PRINT WAS RECORDED DURING MANUFACTURE OF THIS BATCH AND SEVERAL INSTANCES OF MARKER DOWN TIME. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7190529 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE: (B)(6). INITIAL REPORTER PHONE CELL: (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 THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE WAS MISSING THE NUMERIC SCALE MARKINGS. FOUND BEFORE USE. NO SERIOUS INJURIES OR MEDICAL INTERVENTIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911787 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7190529 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other