BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 12555244 · Received September 30, 2021

    Report

    Report Number
    2243072-2021-02417
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE SBD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER APPEARS STUCK AND UNABLE TO FLUSH. THE BORE APPEARS TOO SMALL FOR THE PLUNGER. THIS IS THE 4TH FLUSH SYRINGE THAT HAS DONE THIS. ALSO WHEN TRYING TO ASPIRATE, THE PLUNGER APPEARS STUCK INSIDE AND UNABLE TO ASPIRATE. D2: MEDICAL DEVICE BRAND NAME: BD POSIFLUSH¿ NORMAL SALINE SYRINGE; D4: MEDICAL DEVICE CATALOG # 306546; D4: MEDICAL DEVICE LOT #: 1154859; D4: MEDICAL DEVICE EXPIRATION DATE: 2024-05-31; D4: UDI # (B)(4). D4: BD MEDICAL (BD WEST) MEDICAL SURGICAL COLUMBUS; G4: BD MEDICAL (BD WEST) MEDICAL SURGICAL COLUMBUS; G.5. PMA / 510(K)#: K003553; H4: DEVICE MANUFACTURE DATE 2021-06-03. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-18. H6: INVESTIGATION SUMMARY. IT IS REPORTED THE CUSTOMER IS HAVING DIFFICULTY MOVING THE PLUNGER. TO AID IN THE INVESTIGATION, ONE EMPTY SAMPLE WITH NO PACKAGING FLOW WRAP WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND THE RESULT WAS 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 306546, LOT NUMBER 1154859. 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¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER APPEARS STUCK AND UNABLE TO FLUSH. THE BORE APPEARS TOO SMALL FOR THE PLUNGER. THIS IS THE 4TH FLUSH SYRINGE THAT HAS DONE THIS. ALSO WHEN TRYING TO ASPIRATE, THE PLUNGER APPEARS STUCK INSIDE AND UNABLE TO ASPIRATE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD POSIFLUSH SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER APPEARS STUCK AND UNABLE TO FLUSH. THE BORE APPEARS TOO SMALL FOR THE PLUNGER. THIS IS THE 4TH FLUSH SYRINGE THAT HAS DONE THIS. ALSO WHEN TRYING TO ASPIRATE, THE PLUNGER APPEARS STUCK INSIDE AND UNABLE TO ASPIRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456087 BD POSIFLUSH¿ NORMAL SALINE SYRINGE PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1154859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown