BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 11980357 · Received June 10, 2021

    Report

    Report Number
    1911916-2021-00551
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-07-02. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THE PREFILLED SALINE SYRINGES STOPPED INSTILLING SALINE WHEN THE PLUNGER IS PUSHED IN. TO AID IN THE INVESTIGATION, THIRTY-SIX SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THIRTY SAMPLES ARE UNUSED IN A SHELF BOX. SIX ARE IN PLASTIC BAGS AND ARE CONTAMINATED WITH BLOOD. DUE TO SAFETY REASONS, NO FURTHER ANALYSIS WAS PERFORMED ON THESE SIX SAMPLES. A VISUAL INSPECTION WAS COMPLETED ON THE THIRTY UNUSED SAMPLES AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH OF THESE UNUSED SAMPLES WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND ALL RESULTS WERE WITHIN SPECIFICATION. IT COULD BE POSSIBLE THAT THE CUSTOMER IS GETTING SOME PRODUCTS THAT ARE TOWARDS THE HIGH SPECIFICATION LIMIT AND ARE RELATED TO THE SYMPTOM REPORTED BY THE CUSTOMER SINCE THEY REQUIRE EXTRA FORCE THAN NORMAL TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575, LOT NUMBERS 1082947, 0352370, AND 0352383. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT IMPROPER SILICONE APPLICATION WITHIN THE SYRINGE BARREL CAN CREATE PLUNGER RESISTANCE. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE SILICONE APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE SILICONE IS UNIFORMLY APPLIED TO THE SYRINGE BARREL. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% PLUNGER WAS DIFFICULT TO PUSH WHILE INSTILLING SALINE. THIS OCCURRED ONCE EACH IN LOTS 0352370, 0352383, AND 1082947. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AGAIN COME ACROSS 10 ML PREFILLED SALINE SYRINGES WHICH STOP INSTILLING SALINE WHEN THE PLUNGER IS PUSHED IN.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0352370, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0352383, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 1082947, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: (B)(6) 2021. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THE PREFILLED SALINE SYRINGES STOPPED INSTILLING SALINE WHEN THE PLUNGER IS PUSHED IN. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT COULD BE POSSIBLE THAT THE CUSTOMER IS GETTING SOME PRODUCTS THAT ARE TOWARDS THE HIGH SPECIFICATION LIMIT AND ARE RELATED TO THE SYMPTOM REPORTED BY THE CUSTOMER SINCE THEY REQUIRE EXTRA FORCE THAN NORMAL TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575, LOT NUMBER 0352370. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575, LOT NUMBER 0352383. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575, LOT NUMBER 1082947. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT IMPROPER SILICONE APPLICATION WITHIN THE SYRINGE BARREL CAN CREATE PLUNGER RESISTANCE. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE SILICONE APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE SILICONE IS UNIFORMLY APPLIED TO THE SYRINGE BARREL. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% PLUNGER WAS DIFFICULT TO PUSH WHILE INSTILLING SALINE. THIS OCCURRED ONCE EACH IN LOTS 0352370, 0352383, AND 1082947. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AGAIN COME ACROSS 10 ML PREFILLED SALINE SYRINGES WHICH STOP INSTILLING SALINE WHEN THE PLUNGER IS PUSHED IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876598 BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1082947

    Patients

    Seq Age Sex Outcome Treatment
    1