BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 16969423 · Received May 19, 2023

    Report

    Report Number
    3003152976-2023-00187
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 6, 2023
    Report Date
    June 28, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, LEAKAGE PAST THE STOPPER IS OBSERVED, NO OTHER DEFECT CAN BE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110093, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED. BARREL DO NOT PRESENT ANY DAMAGE THAT COULD HAVE DEFORMED THEIR SHAPE. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DOES NOT SHOW ANY DEFECT. FURTHER TESTING WAS CONDUCTED, NO SIGN OF LEAKAGE OCCURRED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. IT IS A LITTLE COMPLICATED TO SAY THE PERCENTAGE OF DEFECTIVE SYRINGES, BUT APPROXIMATELY 2-3 OUT OF 10. DURING USE THE NURSING STAFF OF THE SERVICE HAVE BEEN DETECTING FAILURES IN THE 50 ML SYRINGES WITH REF: 300865, THE BATCH WE ARE USING RIGHT NOW IS THE 2110093, IT IS IMPOSSIBLE FOR ME TO KNOW IF THIS INCIDENT HAS BEEN DETECTED IN ANY OTHER BATCH. AS I TOLD YOU, THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. IT IS A LITTLE COMPLICATED TO TELL YOU THE PERCENTAGE OF DEFECTIVE SYRINGES, BUT APPROXIMATELY 2-3 OUT OF 10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. IT IS A LITTLE COMPLICATED TO SAY THE PERCENTAGE OF DEFECTIVE SYRINGES, BUT APPROXIMATELY 2-3 OUT OF 10. DURING USE THE NURSING STAFF OF THE SERVICE HAVE BEEN DETECTING FAILURES IN THE 50 ML SYRINGES WITH REF: (B)(4), THE BATCH WE ARE USING RIGHT NOW IS THE (B)(4), IT IS IMPOSSIBLE FOR ME TO KNOW IF THIS INCIDENT HAS BEEN DETECTED IN ANY OTHER BATCH. AS I TOLD YOU, THESE SYRINGES ARE USED TO LOAD CYTOSTATICS AND MEDICATION LEAKAGE HAS BEEN DETECTED BETWEEN THE PLUNGER AND THE BODY OF THE SYRINGE. IT IS A LITTLE COMPLICATED TO TELL YOU THE PERCENTAGE OF DEFECTIVE SYRINGES, BUT APPROXIMATELY 2-3 OUT OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006152 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110093 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown