BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9168864 · Received October 8, 2019

    Report

    Report Number
    2243072-2019-02243
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO LOOSE 10ML SYRINGES WERE RECEIVED ALONG WITH TWO OPENED 10ML BLISTER PACKAGES, CONFIRMED TO BE FROM BATCH #9150965 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. AT LEAST ONE SYRINGE HAD VISIBLE UNIDENTIFIED MEDICATION RESIDUE IN THE FLUID PATH. BOTH SYRINGES HAD JAMMED STOPPER DEFECT OBSERVED, WHERE THE STOPPER WAS NOT SEATED PROPERLY ON THE PLUNGER ROD WITH PART OF IT JAMMED AGAINST THE BARREL WALL. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE MEDICATION LEAKED OUT PAST THE PLUNGER WITH AN BD SYRINGE LUER-LOK¿ TIP. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3). IT WAS REPORTED MEDICATION LEAKED OUT OF THE BACK END OF THE PLUNGER. D.1. MEDICAL DEVICE BRAND NAME: BD SYRINGE LUER-LOK¿ TIP. D.1 MEDICAL DEVICE TYPE: FMF. D.2. COMMON DEVICE NAME: PISTON SYRINGE. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS ¿ CANAAN, CT. D.4 MEDICAL DEVICE CATALOG #: 302995. D.4. MEDICAL DEVICE LOT #: 9150965. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2 MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS ¿ CANAAN, CT. H.4. DEVICE MANUFACTURE DATE: 2019-05-30 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEDICATION LEAKED OUT PAST THE PLUNGER WITH AN BD SYRINGE LUER-LOK¿ TIP. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3) IT WAS REPORTED MEDICATION LEAKED OUT OF THE BACK END OF THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEDICATION LEAKED OUT PAST THE PLUNGER WITH AN BD SYRINGE LUER-LOK¿ TIP. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3) IT WAS REPORTED MEDICATION LEAKED OUT OF THE BACK END OF THE PLUNGER.

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICATION LEAKED OUT PAST THE PLUNGER WITH AN UNSPECIFIED BD 10ML SYRINGE. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3) IT WAS REPORTED MEDICATION LEAKED OUT OF THE BACK END OF THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959310 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9150965

    Patients

    Seq Age Sex Outcome Treatment
    1 Other