BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8628670 · Received May 21, 2019

    Report

    Report Number
    9616657-2019-00213
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WERE 3 SAMPLE RECEIVED BUT DUE TO THE SAMPLES BEING CONTAMINATED A COMPLAINT ANALYSIS COULD NOT BE PERFORMED. AN INTERNAL REVIEW OF THE HISTORY FILES WAS COMPLETED FOR THE REPORTED BATCH NUMBER(S), CONFIRMING PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR THE PRODUCT TO BE RELEASED WERE MET. A ROOT CAUSE COULD NOT BE DETERMINED THROUGH THIS INVESTIGATION AS A COMPREHENSIVE SAMPLE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: PMA / 510(K)#: K141311.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES WHERE THE PLUNGER WAS NOT ABLE TO BE DEPRESSED WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 8324561 IT WAS REPORTED THAT THE SYRINGES STOP HALFWAY THROUGH THE IV FLUSH BECAUSE THE PLUNGER CANNOT BE DEPRESSED ALL THE WAY. PER RESPONSE EMAIL: 2 EVENTS TODAY, (B)(6) 2019. I DO NOT HAVE ANY PATIENT DEMOGRAPHICS FOR YOU BUT THE EVENTS OCCURRED WHILE FLUSHING PATIENT IV'S AT ERR IMAGING. TAKEN FROM ATTACHED EMAIL: "I OVERSEE SUPPLY CHAIN FOR IMAGING SCIENCES AND ONE OF MY STAFF MEMBERS CONTACTED ME BECAUSE WE ARE HAVING ISSUES WITH THE 10CC SALINE SYRINGE CATALOG # 306546. THE NURSING STAFF NOTICED THAT SOME OF THE SYRINGES ALWAYS STOP IN THE MIDDLE AND THEY ARE HAVING A HARD TIME FLUSHING THE IV. THE LOT NUMBER NOTED WAS 8324561. SOME IV CATHETERS WERE REMOVED DURING OCCURRENCE AND ONLY TO DISCOVER THE IV WAS FINE, BUT THE FLUSH PLUNGER SIMPLY WOULD NOT DEPRESS ALL THE WAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES WHERE THE PLUNGER WAS NOT ABLE TO BE DEPRESSED WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 8324561 IT WAS REPORTED THAT THE SYRINGES STOP HALFWAY THROUGH THE IV FLUSH BECAUSE THE PLUNGER CANNOT BE DEPRESSED ALL THE WAY. PER RESPONSE EMAIL: 2 EVENTS TODAY, 5/6/2019. I DO NOT HAVE ANY PATIENT DEMOGRAPHICS FOR YOU BUT THE EVENTS OCCURRED WHILE FLUSHING PATIENT IV'S AT ERR IMAGING. TAKEN FROM ATTACHED EMAIL: "I OVERSEE SUPPLY CHAIN FOR IMAGING SCIENCES AND ONE OF MY STAFF MEMBERS CONTACTED ME BECAUSE WE ARE HAVING ISSUES WITH THE 10CC SALINE SYRINGE CATALOG # 306546. THE NURSING STAFF NOTICED THAT SOME OF THE SYRINGES ALWAYS STOP IN THE MIDDLE AND THEY ARE HAVING A HARD TIME FLUSHING THE IV. THE LOT NUMBER NOTED WAS 8324561. SOME IV CATHETERS WERE REMOVED DURING OCCURRENCE AND ONLY TO DISCOVER THE IV WAS FINE, BUT THE FLUSH PLUNGER SIMPLY WOULD NOT DEPRESS ALL THE WAY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES WHERE THE PLUNGER WAS NOT ABLE TO BE DEPRESSED WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546, BATCH NO.: 8324561. IT WAS REPORTED THAT THE SYRINGES STOP HALFWAY THROUGH THE IV FLUSH BECAUSE THE PLUNGER CANNOT BE DEPRESSED ALL THE WAY. PER RESPONSE EMAIL: 2 EVENTS TODAY, (B)(6) 2019. I DO NOT HAVE ANY PATIENT DEMOGRAPHICS FOR YOU BUT THE EVENTS OCCURRED WHILE FLUSHING PATIENT IV'S AT ERR IMAGING. TAKEN FROM ATTACHED EMAIL: "I OVERSEE SUPPLY CHAIN FOR IMAGING SCIENCES AND ONE OF MY STAFF MEMBERS CONTACTED ME BECAUSE WE ARE HAVING ISSUES WITH THE 10CC SALINE SYRINGE CATALOG # 306546. THE NURSING STAFF NOTICED THAT SOME OF THE SYRINGES ALWAYS STOP IN THE MIDDLE AND THEY ARE HAVING A HARD TIME FLUSHING THE IV. THE LOT NUMBER NOTED WAS 8324561. SOME IV CATHETERS WERE REMOVED DURING OCCURRENCE AND ONLY TO DISCOVER THE IV WAS FINE, BUT THE FLUSH PLUNGER SIMPLY WOULD NOT DEPRESS ALL THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423371 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 8324561 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other