BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    MDR report key: 17786502 · Received September 20, 2023

    Report

    Report Number
    1911916-2023-00678
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 25, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 20-SEP-2023 H6: INVESTIGATION SUMMARY IT WAS REPORTED THE FLUSHES ARE STICKING. TO AID IN THE INVESTIGATION, TWO SAMPLES IN SEALED PACKAGING FLOW WRAPS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE PER IT287, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND ALL RESULTS WERE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 3072507. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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 POSIFLUSH¿ NORMAL SALINE SYRINGES THE PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED 480 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE STARTED LAST WEEK NOT SURE OF THE EXACT DATE BUT COULD OF BEEN THURSDAY OR FRIDAY. CUSTOMER STATES THEY USE THEM TO FLUSH BLOOD OUT OF CATHETERS, STATE THAT THEY ARE STICKING AND THEY ARE PUSHING SO HARD TO PUSH THE SALINE OUT THAT THEY ARE AFRAID DAMAGING PATIENT'S VEINS FROM ALL THE PRESSURE OR HAVING TO REMOVE AND REPLACE CATHETERS. THEY WANT TO AVOID THAT AND DO NOT FEEL COMFORTABLE USING THE PRODUCT BUT THEY ARE USING IT UNTIL THEY CAN GET SOME REPLACEMENTS FROM THEIR SUPPLIER. THE PLUNGER IS HARD TO PUSH BUT THERE APPEARS TO BE A STICKING POINT BUT ONCE THEY ARE ABLE TO GET PASS THAT THEN THEY CAN USE IT BUT THEY HAVE TO USE A LOT OF PRESSURE AND THEY FEEL THE LOT IS FAULTY. MAT # 306546, LOT 3072507. ISSUE HAS OCCURRED WITH AROUND 45EA. THEY DO NOT HAVE SAMPLES OF THE ACTUAL PRODUCT TO SEND BACK THAT HAS HAD THE ISSUE. THEY DO HAVE REPRESENTATIVE SAMPLES TO SEND IN. THEY DO NOT HAVE ANY PHOTOS OF THE PRODUCT THAT THE ISSUE HAS OCCURRED WITH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES THE PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED 480 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE STARTED LAST WEEK NOT SURE OF THE EXACT DATE BUT COULD OF BEEN THURSDAY OR FRIDAY. CUSTOMER STATES THEY USE THEM TO FLUSH BLOOD OUT OF CATHETERS, STATE THAT THEY ARE STICKING AND THEY ARE PUSHING SO HARD TO PUSH THE SALINE OUT THAT THEY ARE AFRAID DAMAGING PATIENT'S VEINS FROM ALL THE PRESSURE OR HAVING TO REMOVE AND REPLACE CATHETERS. THEY WANT TO AVOID THAT AND DO NOT FEEL COMFORTABLE USING THE PRODUCT BUT THEY ARE USING IT UNTIL THEY CAN GET SOME REPLACEMENTS FROM THEIR SUPPLIER. THE PLUNGER IS HARD TO PUSH BUT THERE APPEARS TO BE A STICKING POINT BUT ONCE THEY ARE ABLE TO GET PASS THAT THEN THEY CAN USE IT BUT THEY HAVE TO USE A LOT OF PRESSURE AND THEY FEEL THE LOT IS FAULTY. MAT # 306546. LOT 3072507. ISSUE HAS OCCURRED WITH AROUND 45EA. THEY DO NOT HAVE SAMPLES OF THE ACTUAL PRODUCT TO SEND BACK THAT HAS HAD THE ISSUE. THEY DO HAVE REPRESENTATIVE SAMPLES TO SEND IN. THEY DO NOT HAVE ANY PHOTOS OF THE PRODUCT THAT THE ISSUE HAS OCCURRED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446895 BD POSIFLUSH¿ NORMAL SALINE SYRINGES, SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 3072507 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown