BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 8962546 · Received September 4, 2019

    Report

    Report Number
    2243072-2019-01898
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    July 19, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE MANUFACTURER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED.THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 SYR 10ML PUMPS COMPATIBLE SALINE 10ML FIL EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547, BATCH NO.: 9113775. 0.9 NORMAL SALINE FLUSH (10ML FLUSH) BROKEN OFF INTO THE MED TUBING WHEN SWITCHING THE SYRINGE OUT (TWICE). D.1. MEDICAL DEVICE BRAND NAME: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL. D.1. COMMON DEVICE NAME: SALINE, VASCULAR ACCESS FLUSH. D.2. MEDICAL DEVICE TYPE: NGT. D.4. MEDICAL DEVICE CATALOG #: 306547. D.4. MEDICAL DEVICE LOT #: 9113775. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL (BD WEST) MEDICAL SURGICAL. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BD MEDICAL (BD WEST) MEDICAL SURGICAL. G.5. PMA/510(K)#: K161552. H.4. DEVICE MANUFACTURE DATE: 2019-04-23.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYR 10ML PUMPS COMPATIBLE SALINE 10ML FIL EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547, BATCH NO.: 9113775. 0.9 NORMAL SALINE FLUSH (10ML FLUSH) BROKEN OFF INTO THE MED TUBING WHEN SWITCHING THE SYRINGE OUT (TWICE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYR 10ML PUMPS COMPATIBLE SALINE 10ML FIL EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547; BATCH NO.: 9113775. 0.9 NORMAL SALINE FLUSH (10ML FLUSH) BROKEN OFF INTO THE MED TUBING WHEN SWITCHING THE SYRINGE OUT (TWICE).

    Additional Manufacturer Narrative · 1

    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. 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 2 UNSPECIFIED BD SYRINGES EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN, BATCH NO.: UNKNOWN. 0.9 NORMAL SALINE FLUSH (10 ML FLUSH) BROKEN OFF INTO THE MED TUBING WHEN SWITCHING THE SYRINGE OUT (TWICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753711 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9113775

    Patients

    Seq Age Sex Outcome Treatment
    1 Other