BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML CT

    MDR report key: 10399814 · Received August 12, 2020

    Report

    Report Number
    3003152976-2020-00358
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1910282, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. RESULTS FOR THE REPORTED LOT WERE REVIEWED AND FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 50ML CT PLUNGER WAS DIFFICULT TO MOVE AND "SPRANG BACK" WHEN ATTEMPTING TO USE IT. THIS OCCURRED WITH 2 SYRINGES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT ADVISED THAT TWO OF THE SYRINGES "SPRANG BACK" WHEN SHE TRIED TO USE THEM, WHICH SHOULD NOT CLARIFY WHAT THAT MEANT. I ASKED IF THIS WAS THE PLUNGER SPRINGING BACK AND SHE COULD NOT CONFIRM, JUST ADVISED THAT, BECAUSE THESE SYRINGES DID NOT HAVE A LOCKING MECHANISM ON THEM THEY SPRUNG BACK WHEN SHE TRIED TO USE THEM." "1. DATE OF EVENT. IS IT THE SAME AS DATE COMPLAINT REPORTED? - PATIENT DOES NOT RECALL DATE, ADVISED IT HAPPENED ON TWO SEPARATE OCCASIONS, A FEW DAYS APART. 2. WAS THE COURSE OF TREATMENT CHANGED? - NO CHANGES TO TREATMENT, PATIENT WAS ADMINISTERING FLUSHES AS USUAL. 3. ANY EXPOSURE TO BLOOD/BODILY FLUID? - YES, PATIENT ADVISED ON THOSE TWO OCCASIONS, SHE PASSED BLOOD AFTER THE CATHETERS DRAINED. SHE HAS NOT PASSED BLOOD SINCE, ONLY WHEN FLUSHING THOSE TWO TIMES. 4. ANY MEDICAL INTERVENTION? - PATIENT ADVISED NO INTERVENTION OR MEDICAL ADVICE SOUGHT OUT. 5. ANY OTHER ACTION? - PATIENT ADVISED SHE IS ON SEVERAL MEDICATIONS SO SHE JUST TOOK SOME PARACETAMOL AFTER THE INCIDENT AS IT CAUSED SOME DISCOMFORT IN HER BLADDER BUT WAS FINE AFTER A WHILE. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 50 ML CT PLUNGER WAS DIFFICULT TO MOVE AND "SPRANG BACK" WHEN ATTEMPTING TO USE IT. THIS OCCURRED WITH 2 SYRINGES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT ADVISED THAT TWO OF THE SYRINGES "SPRANG BACK" WHEN SHE TRIED TO USE THEM, WHICH SHOULD NOT CLARIFY WHAT THAT MEANT. I ASKED IF THIS WAS THE PLUNGER SPRINGING BACK AND SHE COULD NOT CONFIRM, JUST ADVISED THAT, BECAUSE THESE SYRINGES DID NOT HAVE A LOCKING MECHANISM ON THEM THEY SPRUNG BACK WHEN SHE TRIED TO USE THEM." "DATE OF EVENT. IS IT THE SAME AS DATE COMPLAINT REPORTED? PATIENT DOES NOT RECALL DATE, ADVISED IT HAPPENED ON TWO SEPARATE OCCASIONS, A FEW DAYS APART. WAS THE COURSE OF TREATMENT CHANGED? NO CHANGES TO TREATMENT, PATIENT WAS ADMINISTERING FLUSHES AS USUAL. ANY EXPOSURE TO BLOOD/BODILY FLUID? YES, PATIENT ADVISED ON THOSE TWO OCCASIONS, SHE PASSED BLOOD AFTER THE CATHETERS DRAINED. SHE HAS NOT PASSED BLOOD SINCE, ONLY WHEN FLUSHING THOSE TWO TIMES. ANY MEDICAL INTERVENTION? PATIENT ADVISED NO INTERVENTION OR MEDICAL ADVICE SOUGHT OUT. ANY OTHER ACTION? PATIENT ADVISED SHE IS ON SEVERAL MEDICATIONS SO SHE JUST TOOK SOME PARACETAMOL AFTER THE INCIDENT AS IT CAUSED SOME DISCOMFORT IN HER BLADDER BUT WAS FINE AFTER A WHILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864019 SYRINGE 50ML CT PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1910282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other