BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II SYRINGE

    MDR report key: 9233349 · Received October 24, 2019

    Report

    Report Number
    1920898-2019-01186
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 11, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1/2CC, 8MM, 30G SYRINGES IN OPEN POLY BAG FROM LOT # 8043594. CUSTOMER STATES THAT SHE COULD NOT PULL THE PLUNGER BACK, THE BLACK TIP LOOKED ABNORMAL, AND THE PLUNGER, CAP, AND BARREL WERE BROKEN. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A DEFORMED STOPPER IN THE BARREL, WHICH COULD PREVENT THE PLUNGER FROM BEING DRAWN BACK. THE REMAINING SYRINGE EXHIBITED A BROKEN PLUNGER ROD, CRACKED PLUNGER CAP, AND CRACKS IN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8043594. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 28OCT2019, HOLDREGE RECEIVED A COMPLAINT, VIA PICTURES, FROM MATERIAL 320468, BATCH 8043594. THE SAMPLES WERE REQUESTED, AND ARRIVED IN HOLDREGE ON 05NOV2019. THE SAMPLES WERE TWO 0.5ML SYRINGES IN AN OPEN POLYBAG. THE SAMPLES WERE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. VISUAL INSPECTION OF THE FIRST SYRINGE FOUND THE STOPPER SMEARED UP AGAINST THE SIDE OF THE PLUNGER. WHEN THE STOPPER WAS REMOVED, IT REMAINED IN ITS DEFORMED SHAPE. THERE WAS A LIGHT APPLICATION OF SILICONE IN THE BARREL. NO OTHER DAMAGE WAS OBSERVED. VISUAL INSPECTION OF THE SECOND SYRINGE FOUND THE BARREL CRACKED FROM THE 23 TO THE 47 SCALE MARK. THERE WAS ALSO A SMALL GOUGE AT THE 25 SCALE MARK. THE BARREL FROM JUST BELOW THE FLANGE TO THE TOP OF THE BARREL, THE PLUNGER, AND THE CAP WERE CUT JAGGEDLY ON A DIAGONAL. ASSEMBLY MACHINE PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.5ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIMEFRAME OF THIS BATCH THAT PERTAINED TO THESE DEFECTS. ROOT CAUSE CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ II SYRINGE PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320468 BATCH NO: 8043594. IT WAS REPORTED THAT THE CUSTOMER PULLED ONE FROM THE BAG AND COULD NOT PULL THE PLUNGER BACK AND SHE NOTED THAT THE SOFT BLACK TIP OF GE PLUNGER LOOKED ABNORMAL . CONSUMER STATED THAT THE NEXT STRING SHE PULLED FROM THE BAG ALSO HAD A PROBLEM. WHEN SHE REMOVED THE CAP OVER THE PLUNGER END THE END OF THE PLUNGER WAS FOUND TO BE BROKEN OFF. ON FURTHER INSPECTION THE CAP AND END OF THE STRING BARREL WERE BROKEN. VERBATIM: I USE BD ULTRA FINE 1/2 ML 8MM 30G SYRINGE/NEEDLE COMBOS. TODAY I PULLED ONE FROM THE BAG AND COULD NOT PULL THE PLUNGER BACK. I NOTED THAT THE SOFT BLACK TIP OF PLUNGER LOOKED ABNORMAL SO I SET IT ASIDE. THE NEXT STRING I PULLED FROM THE BAG ALSO HAD A PROBLEM. WHEN I REMOVED THE CAP OVER THE PLUNGER END THE END OF THE PLUNGER WAS FOUND TO BE BROKEN OFF. ON FURTHER INSPECTION THE CAP AND END OF THE STRING BARREL WERE BROKEN. THE REMAINING SYRINGES IN THE BAG LOOKED NORMAL. I TRIED TO LOOK AT THE REST OF THE SYRINGES IN THE BOX OF 400 BUT COULD NOT SEE THROUGH THE PACKAGING. I AM A NURSE AND KNOW THAT THE OCCASIONAL SYRINGE CAN BE DAMAGED OR ABNORMAL BUT IT SEEMED STRANGE TO FIND 2 IN A BAG OF 10.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 ULTRA-FINE¿ II SYRINGE PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320468 BATCH NO: 8043594. IT WAS REPORTED THAT THE CUSTOMER PULLED ONE FROM THE BAG AND COULD NOT PULL THE PLUNGER BACK AND SHE NOTED THAT THE SOFT BLACK TIP OF GE PLUNGER LOOKED ABNORMAL . CONSUMER STATED THAT THE NEXT STRING SHE PULLED FROM THE BAG ALSO HAD A PROBLEM. WHEN SHE REMOVED THE CAP OVER THE PLUNGER END THE END OF THE PLUNGER WAS FOUND TO BE BROKEN OFF. ON FURTHER INSPECTION THE CAP AND END OF THE STRING BARREL WERE BROKEN. VERBATIM: I USE BD ULTRA FINE 1/2 ML 8MM 30G SYRINGE/NEEDLE COMBOS. TODAY I PULLED ONE FROM THE BAG AND COULD NOT PULL THE PLUNGER BACK. I NOTED THAT THE SOFT BLACK TIP OF PLUNGER LOOKED ABNORMAL SO I SET IT ASIDE. THE NEXT STRING I PULLED FROM THE BAG ALSO HAD A PROBLEM. WHEN I REMOVED THE CAP OVER THE PLUNGER END THE END OF THE PLUNGER WAS FOUND TO BE BROKEN OFF. ON FURTHER INSPECTION THE CAP AND END OF THE STRING BARREL WERE BROKEN. THE REMAINING SYRINGES IN THE BAG LOOKED NORMAL. I TRIED TO LOOK AT THE REST OF THE SYRINGES IN THE BOX OF 400 BUT COULD NOT SEE THROUGH THE PACKAGING. I AM A NURSE AND KNOW THAT THE OCCASIONAL SYRINGE CAN BE DAMAGED OR ABNORMAL BUT IT SEEMED STRANGE TO FIND 2 IN A BAG OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030614 BD ULTRA-FINE II SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 8043594

    Patients

    Seq Age Sex Outcome Treatment
    1 Other