BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 10051336 · Received May 13, 2020

    Report

    Report Number
    2243072-2020-00762
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 1, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-02. H.6. INVESTIGATION SUMMARY : ONE SAMPLE WAS RECEIVED FOR EVALUATION. IT CAME IN A ZIPLOC PLASTIC BAG TOGETHER WITH AN EXTENSION SET. THE SYRINGE HAS THE PLUNGER ROD RUBBER STOPPER ALL THE WAY DOWN, THEREFORE, NO SALINE SOLUTION. IT HAS NO TIP CAP. THE BARREL LABEL CONFIRMS THE LOT# 9340052. THE PLUNGER ROD-RUBBER STOPPER WAS PULLED UP TO THE 10ML SCALE MARKING. THE SUSTAINING FORCE WAS MEASURED GIVING A 10.6N VALUE. THE SPECIFICATION IS <20N. THE ROOT CAUSE OF REPORTED CONDITION COULD NOT BE CONFIRMED. IN ADDITION, FIVE PHOTOS WERE PROVIDED FOR EVALUATION. ONE PHOTO SHOWS A REPORT, ANOTHER PHOTO SHOWS THE SYRINGE AND THE EXTENSION SET IN THE PLASTIC BAG, THE OTHER THREE PHOTOS ARE FROM THE BARREL LABEL CONFIRMING THE LOT# 9340052. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 9340052 IT WAS REPORTED THAT THE TRIFUSE EXTENSION SET WOULD NOT PRIME NORMAL SALINE. ALTHOUGH TREATMENT WAS DELAYED, THERE WERE NO ADVERSE AFFECTS TO THE INFANT PATIENT. THE EVENT OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: WITHOUT KNOWING EITHER THE BATCH/LOT # OR MANUFACTURING SITE, THE PMA/510(K)# FOR THIS DEVICE MAY BE EITHER K161552 OR K141311. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 9340052. IT WAS REPORTED THAT THE TRIFUSE EXTENSION SET WOULD NOT PRIME NORMAL SALINE. ALTHOUGH TREATMENT WAS DELAYED, THERE WERE NO ADVERSE AFFECTS TO THE INFANT PATIENT. THE EVENT OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517851 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 306546 UNKNOWN 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other