BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL SYRINGE S2

    MDR report key: 18619867 · Received January 31, 2024

    Report

    Report Number
    3002682307-2024-00017
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    December 13, 2023
    Report Date
    May 17, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    50382903003308
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300330 AND LOT NUMBER 2203271. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. UPON REVIEW, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF LEAKAGE. THE REPORTED LEAKAGE MAY HAVE BEEN CAUSED BY DAMAGE IN THE PLUNGER, WHICH COULD HAVE OCCURRED DURING THE HANDLING OF THE PRODUCT IN THE MANUFACTURING PROCESS/PLUNGER ASSEMBLY MACHINE. IF THIS INCIDENT WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THE AFFECTED SAMPLE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL SYRINGE S2 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: 06:30 PATIENT IS TAKEN TO THE HD ROOM IN GOOD GENERAL CONDITION, ORIENTED IN THE FIVE SPHERES, WALKING BY HIS OWN MEANS, WITHOUT GAIT DISTURBANCE, ASYMPTOMATIC. HE IS TRANSFERRED TO A STATION DESIGNATED BY THE NURSING ASSISTANT APPLYING THE PATIENT'S SAFETY PROTOCOL AFTER CONNECTION. UF 2.6 LITERS ACCORDING TO TOLERANCE FOR MAXIMUM HOURLY RATE OF UF ACCORDING TO INTERDIALYTIC SANITATION 4 5 KG. NO SIGNS OF WATER OVERLOAD ARE OBSERVED. VITAL SIGNS TAKEN PRIOR TO CONNECTION TO FAV ACCORDING TO PROTOCOL AND START OF THERAPY WITHOUT COMPLICATIONS. BP QBNOM 200ML/MIN: -140 MMHG 07:00 AT CROSS-CHECK WITH THE DOCTOS, NO NOVELTY IS FOUND. 10:00 AT THE TIME OF THE NURSING ROUND, A 20 CC SYRINGE WAS FOUND IN WHICH A DOSE OF IRON SACCHARATE WAS BEING ADMINISTERED ACCORDING TO PRESCRIPTION, WHICH WAS FULL OF BLOOD, DUE TO THE FACT THAT THE EMBOLUS HAD NO PRESSURE AND ALLOWED THE BLOOD TO PASS TO THE OUTSIDE OF THE SYRINGE, THE SYRINGE WAS IMMEDIATELY CLAMPED. HOWEVER, IT WAS FOUND THAT THE BLOOD CONTENT LEAKED THROUGH THE SLOTS OF THE MACHINE, AS WELL AS THE LANCETS AND THE BIBAG PORT, ENTERING THE INTERIOR OF THE SAME. THERE IS NO EVIDENCE OF SIGNIFICANT BLOOD LOSS, THE PATIENT IS STABLE, WITH NO HEMODYNAMIC COMPLICATIONS. NURSING ASSISTANT PERFORMS EXTERNAL DISINFECTION OF THE MACHINE WITH HYPOCHLORITE 0.3% AND THEN 70% ALCOHOL. IT IS PERFORMED THE REPORT TO THE PHARMACY AND TECHNICAL MAINTENANCE STAFF. 10:40 TERMINATES SCHEDULED TIME, IT IS RETURNED VOLEMIA, REMOVAL OF NEEDLES LEAVING GAUZE FOR HEMOSTASIS, SUBSEQUENT CHANGE OF DRESSING PERFORMED BY NURSING ASSISTANT. PATIENT TOLERATED UF PROGRAMMED, LEAVING IN GOOD GENERAL CONDITION, ORIENTED AND ASYMPTOMATIC. FUNCTIONAL VASCULAR ACCESS. IN DRY WEIGHT. NURSE ASSISTANT PERFORMS DISASSEMBLY, EXTERNAL CLEANING WITH A CLOTH IMPREGNATED WITH ALCOHOL 70%. CASALIMPIA STAFF PERFORMS DISINFECTION OF CHAIR, CUSHION AND CONTROL WITH ALCOHOL 70%. __ THERE WAS NO PATIENT DAMAGE. ACTIONS TAKEN: VOLUME REPLACEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109499 BD CONVENTIONAL SYRINGE S2 SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 2203271 50382903003308

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male