BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 8160324 · Received December 13, 2018

    Report

    Report Number
    1213809-2018-00889
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 26, 2018
    Report Date
    January 29, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE SCALE PRINTING ON THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD BLURRED/DOUBLE-PRINTED NUMBERS AND GRADUATION LINES. THERE WERE 58 OCCURRENCES ON LOT # 8145680 FOR THIS DATE AND 13 OCCURRENCES FOR LOT # 8222764 FOR THIS DATE. THERE WERE OTHER OCCURRENCES ON DIFFERENT DATES CAPTURED IN RELATED COMPLAINTS. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. EACH PHOTO DEPICTED A 5ML SYRINGE FILLED WITH CLEAR LIQUID AND A TIP CAP ATTACHED. IT IS UNKNOWN WHICH BATCH EACH SAMPLE IN THE PHOTOS BELONGS TO. ADDITIONAL 6 PHOTOS WERE RECEIVED. THE PHOTOS SHOWED FILLED 5ML SYRINGES WITH BLUE TIP CAPS ATTACHED. THE BARRELS HAD VARYING DEGREES OF MISSING PRINT, PRIMARILY IN THE FIRST FEW GRAD LINES CLOSE TO THE ZERO LINE. 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 ADJUSTMENTS AT PRINTER WERE RECORDED DURING THE MANUFACTURE OF BATCHES 8128506. OUT OF THE 7 BATCHES PROVIDED, 5 WERE MANUFACTURED AT OUR PLANT: 8128506, 8145680, 8222764, 8119614 AND 8119628 ¿ WHILE THE OTHER TWO ARE NOT IN OUR SYSTEM. INVESTIGATION CONCLUSION: PHOTO 1 AND 2 BOTH SHOWED BLUE CAPPED SYRINGES WITH SLIGHT DOUBLE PRINT OF THE SCALE MARKINGS VISIBLE. THE DOUBLE PRINT OBSERVED WAS LATERAL ONLY. THE ITEMS WERE STILL LEGIBLE AND VOLUMETRIC ACCURACY NOT COMPROMISED. THE PRINT OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. PHOTO 3 SHOWED A RED CAPPED SYRINGE WITH A LATERAL DOUBLE PRINT VISIBLE. THE DOUBLE PRINT OBSERVED CREATED CLEARLY VISIBLE DOUBLING OF NUMBERS AND IS REJECTABLE PER PRODUCT SPECIFICATION. 2 OUT OF THE 6 PHOTOS PROVIDED SHOWED REJECTABLE MISSING PRINT, WHILE 4 HAD ACCEPTABLE PRINT PER PRODUCT SPECIFICATION. THE REJECTABLE SAMPLES SHOWED OVER 50% OF AT LEAST ONE ITEM, SUCH AS GRADUATED LINE OR NUMBER, MISSING. THE ACCEPTABLE SAMPLES ALL HAD SMALL AMOUNTS OF PRINT MISSING WITH LESS THAN 50% OF ANY ONE ITEM MISSING AND ALL OF THE ITEMS LEGIBLE. THE SCALE WAS STILL LEGIBLE IN THESE CASES. ROOT CAUSE DESCRIPTION: BASED UPON THE PICTURES AND THE BATCH NUMBERS PROVIDED WE BELIEVE THAT THIS PRINT DEFECT IS ASSOCIATED WITH ONE SINGLE BATCH SINCE THE DEFECT APPEARS TO HAVE WORSENED OVER TIME. PERHAPS THE MIXING OF BD LOTS AT THE FACILITY COULD EXPLAIN THE INVOLVEMENT OF 7 BATCHES WITH THIS ISSUE. CUSTOMER CONFIRMED THEY UTILIZE THE FIFO PROCESS. IF DURING THE PICKING PROCESS A MANUFACTURING LOT NUMBER IS DEPLETED THEY WOULD UTILIZE AN ADDITIONAL MANUFACTURING LOT NUMBER. THIS WOULD CAUSE THE BATCH NUMBERS TO SOMETIMES USE MULTIPLE MANUFACTURING LOT NUMBERS OF SYRINGES. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE PRINTING ON THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD BLURRED/DOUBLE-PRINTED NUMBERS AND GRADUATION LINES. THERE WERE 58 OCCURRENCES ON LOT # 8145680 FOR THIS DATE AND 13 OCCURRENCES FOR LOT # 8222764 FOR THIS DATE. THERE WERE OTHER OCCURRENCES ON DIFFERENT DATES CAPTURED IN RELATED COMPLAINTS.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8145680, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-05-25. MEDICAL DEVICE LOT #: 8222764, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-08-10. MEDICAL DEVICE LOT #: 8119614, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-29. MEDICAL DEVICE LOT #: 8119628, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-29. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAS BLURRED SCALE MARKINGS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998602 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other