BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 9266103 · Received November 1, 2019

    Report

    Report Number
    1213809-2019-01092
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 17, 2019
    Report Date
    January 23, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    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: ONE PHOTO AND FOUR LOOSE 5ML SYRINGES CONTAINING DIFFERENT AMOUNTS OF CLEAR FLUID WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL THE SYRINGE APPEARED TO HAVE LEAKAGE PAST BOTH RIBS OF THE STOPPER. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER IS UNDETERMINED. A PHYSICAL UNUSED SAMPLE IS REQUIRED FOR LEAKAGE TESTING AND A MORE THOROUGH EVALUATION. THE ROOT CAUSE IS UNDETERMINED. THE PLUNGER ROD MOVEMENT COULD NOT BE TESTED. THE RECEIVED SAMPLES WERE MANIPULATED. BASED ON PHOTOS EVALUATION, FOREIGN MATTER HAS BEEN IDENTIFIED. HOWEVER, BD WAS NOT ABLE TO DUPLICATE OR CONFIRM BY THE CUSTOMER INDICATED FAILURE MODES. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER (S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED DURING USE, SOME HAD PRESSURE BUILD UP WHILE FILLING, CAUSING THE PLUNGER TO "JUMP UP", SOME HAD THEIR PLUNGERS EXHIBIT "STOP AND GO" MOTIONS WHILE FILLING, AND SOME HAD THEIR PLUNGERS "CANT OR SKEW SLIGHTLY" WHEN DRAWING BACK. ADDITIONALLY, OTHER SYRINGES HAD ISSUES WITH FOREIGN PARTICLES FOUND IN THEM DURING USE. LOT #'S 9043817 AND 9077798 WERE REPORTED TO HAVE HAD DEFECTS FOR LEAKAGE, DIFFICULT PLUNGER MOVEMENT, AND FOREIGN MATTER, WHEREAS LOT# 8239796 HAD ONLY DIFFICULT PLUNGER MOVEMENT AND FOREIGN MATTER DEFECTS FOUND IN IT. HOWEVER, IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE IN THE PROCESS OF INVESTIGATING PARTICLES AND LEAKING FOUND IN BD 3, 5 AND 20 ML BULK PACKS." "BD PART # 309703 5ML TRAY SYRINGES; TRAY SYRINGES - LOT NUMBERS USED; BD LOT# P = PARTICLES FOUND; L= LEAKING FOUND. 8239796 P; 9043817 P + L; 9077798 P + L." "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."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8239796. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-09-28. MEDICAL DEVICE LOT #: 9043817. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2019-03-21. MEDICAL DEVICE LOT #: 9077798. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-04-01. 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 SOME BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED DURING USE, SOME HAD PRESSURE BUILD UP WHILE FILLING, CAUSING THE PLUNGER TO "JUMP UP", SOME HAD THEIR PLUNGERS EXHIBIT "STOP AND GO" MOTIONS WHILE FILLING, AND SOME HAD THEIR PLUNGERS "CANT OR SKEW SLIGHTLY" WHEN DRAWING BACK. ADDITIONALLY, OTHER SYRINGES HAD ISSUES WITH FOREIGN PARTICLES FOUND IN THEM DURING USE. LOT #'S 9043817 AND 9077798 WERE REPORTED TO HAVE HAD DEFECTS FOR LEAKAGE, DIFFICULT PLUNGER MOVEMENT, AND FOREIGN MATTER, WHEREAS LOT# 8239796 HAD ONLY DIFFICULT PLUNGER MOVEMENT AND FOREIGN MATTER DEFECTS FOUND IN IT. HOWEVER, IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE SECOND OF THREE RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE IN THE PROCESS OF INVESTIGATING PARTICLES AND LEAKING FOUND IN BD 3, 5 AND 20 ML BULK PACKS." "BD PART # 309703 5ML TRAY SYRINGES. TRAY SYRINGES - LOT NUMBERS USED BD LOT# P, PARTICLES FOUND; L, LEAKING FOUND 8239796 P, 9043817 P + L, 9077798 P + L." "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: 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059565 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309703 SEE SECTION H.10. 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other