BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK 3 ML SYRINGE

    MDR report key: 9271627 · Received November 4, 2019

    Report

    Report Number
    1213809-2019-01098
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 17, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097020
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES OF 3ML SYRINGES WERE RECEIVED FOR EVALUATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE THREE PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER LOK¿ 3 ML SYRINGES ARE LEAKING, HAD FOREIGN MATTER, AND THE PLUNGER ROD WAS LOOSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309702 , BATCH NO.: 8143669, 8143668, 8184890. IT WAS REPORTED THAT THE SYRINGES ARE LEAKING. IT WAS ALSO REPORTED THAT PARTICLES ARE BEING FOUND ON THE SYRINGES. IT WAS ALSO REPORTED THAT THE PLUNGER ROD EITHER JUMPS UP, STOPS WHILE FILLING, OR CANTS OR SKEWS UPON DRAWBACK. WE ARE IN THE PROCESS OF INVESTIGATING PARTICLES AND LEAKING FOUND IN BD 3, 5 AND 20 ML BULK PACKS. SECOND IMPORTANT ITEM ¿ SYRINGE LEAKING: WE HAVE TRIED TO INDUCE LEAKING VIA NORMAL HANDLING AND PUMPING AND ABUSIVE HANDLING AND PUMPING. THE GOOD NEWS IS THE SYRINGES APPEAR VERY ROBUST AND WE CANNOT INDUCE LEAKING IN FILLED GOOD SYRINGES. THE LESS GOOD NEWS IS THIS MEANS IT IS MORE LIKELY TO BE INHERENT IN A SUBSET OF THE SYRINGES. WHEN WE FILL THE SYRINGES WE NOTICE MANY FILL SMOOTHLY AND THEN DRAW BACK SMOOTHLY WHEN OUR PUMPS DOES A SMALL INCREMENTAL DRAWBACK (TO REMOVE TIP DROPS DURING TIP FILLING). HOWEVER, SOME SYRINGES EXHIBIT DIFFERENT VISIBLE BEHAVIOR WHEN FILLING. THEY ARE: 1. PRESSURE BUILDS THEN PLUNGER JUMPS UP. 2. PLUNGER EXHIBITS STOP AND GO AS IT FILLS. 3. PLUNGER GOES UP THEN CANTS OR SKEWS SLIGHTLY WHEN THE SMALL DRAW BACK OCCURS. THE DEFINITION OF LEAKING IS TYPICALLY A SINGLE DROP OF LIQUID JUST BEYOND THE MOST OUTSIDE PLUNGER GASKET. OF NOTE - IN MANY CASES LIQUID IS IN BETWEEN THE FIRST AND SECOND PLUNGER SEALS; WE DO NOT COUNT THIS AS A LEAKING SYRINGE. OUR THOUGHTS OF POTENTIAL ROOT CAUSES: A. PLUNGER TO BARREL TOLERANCE DIFFERENCES? B. LITTLE OR NO BARREL OR PLUNGER SILICONE LUBRICANT? C. PLUNGER ELASTOMER DENSITY/HARDNESS VARIANCES? D. EXCESS SILICONE OIL? PLEASE NOTE OUR INCIDENCE OF PARTICLES AND LEAKING IS SIGNIFICANTLY HIGHER ON THE 3 AND 5 ML SYRINGES. THE 20 ML SYRINGE HAS HAD VERY LOW INCIDENCE OF EITHER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8143669. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-21. MEDICAL DEVICE LOT #: 8143668. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-18. MEDICAL DEVICE LOT #: 8184890. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-08-09. 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¿ 3 ML SYRINGES ARE LEAKING, HAD FOREIGN MATTER, AND THE PLUNGER ROD WAS LOOSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309702 BATCH NO.: 8143669, 8143668, 8184890. IT WAS REPORTED THAT THE SYRINGES ARE LEAKING. IT WAS ALSO REPORTED THAT PARTICLES ARE BEING FOUND ON THE SYRINGES. IT WAS ALSO REPORTED THAT THE PLUNGER ROD EITHER JUMPS UP, STOPS WHILE FILLING, OR CANTS OR SKEWS UPON DRAWBACK. WE ARE IN THE PROCESS OF INVESTIGATING PARTICLES AND LEAKING FOUND IN BD 3, 5 AND 20 ML BULK PACKS. SECOND IMPORTANT ITEM: SYRINGE LEAKING. WE HAVE TRIED TO INDUCE LEAKING VIA NORMAL HANDLING AND PUMPING AND ABUSIVE HANDLING AND PUMPING. THE GOOD NEWS IS THE SYRINGES APPEAR VERY ROBUST AND WE CANNOT INDUCE LEAKING IN FILLED GOOD SYRINGES. THE LESS GOOD NEWS IS THIS MEANS IT IS MORE LIKELY TO BE INHERENT IN A SUBSET OF THE SYRINGES. WHEN WE FILL THE SYRINGES WE NOTICE MANY FILL SMOOTHLY AND THEN DRAW BACK SMOOTHLY WHEN OUR PUMP DOES A SMALL INCREMENTAL DRAWBACK (TO REMOVE TIP DROPS DURING TIP FILLING). HOWEVER, SOME SYRINGES EXHIBIT DIFFERENT VISIBLE BEHAVIOR WHEN FILLING. THEY ARE: PRESSURE BUILDS THEN PLUNGER JUMPS UP. PLUNGER EXHIBITS STOP AND GO AS IT FILLS. PLUNGER GOES UP THEN CANTS OR SKEWS SLIGHTLY WHEN THE SMALL DRAW BACK OCCURS. THE DEFINITION OF LEAKING IS TYPICALLY A SINGLE DROP OF LIQUID JUST BEYOND THE MOST OUTSIDE PLUNGER GASKET. OF NOTE, IN MANY CASES LIQUID IS IN-BETWEEN THE FIRST AND SECOND PLUNGER SEALS; WE DO NOT COUNT THIS AS A LEAKING SYRINGE. OUR THOUGHTS OF POTENTIAL ROOT CAUSES: PLUNGER TO BARREL TOLERANCE DIFFERENCES? LITTLE OR NO BARREL OR PLUNGER SILICONE LUBRICANT? PLUNGER ELASTOMER DENSITY/HARDNESS VARIANCES? EXCESS SILICONE OIL? PLEASE NOTE OUR INCIDENCE OF PARTICLES AND LEAKING IS SIGNIFICANTLY HIGHER ON THE 3 AND 5 ML SYRINGES. THE 20 ML SYRINGE HAS HAD VERY LOW INCIDENCE OF EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065071 BD LUER LOK 3 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other