BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8962542 · Received September 4, 2019

    Report

    Report Number
    2243072-2019-01899
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    July 26, 2019
    Report Date
    October 7, 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 FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: SITE LEGAL NAME (FDA): COLUMBUS (WEST). B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE TIP BROKE OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547, BATCH NO.: 9127846. IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE INTO THE TUBING. WHEN GOING TO GIVE MEDICATION THROUGH MEDLINE. THE 0.9 NS SYRINGE WAS REMOVED FROM TUBING AND THE TIP OF THE SYRINGE WAS BROKEN OFF AND REMAINED IN THE TUBING. NEW LINE SET UP WAS MADE AND THE DEFECTIVE TUBING REMOVED AND TURNED IN. D.1. MEDICAL DEVICE BRAND NAME: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, D.2. MEDICAL DEVICE TYPE: NGT, D.2. COMMON DEVICE NAME: SALINE, VASCULAR ACCESS FLUSH, D.3. MEDICAL DEVICE MANUFACTURER: COLUMBUS (WEST), D.2. MEDICAL DEVICE CATALOG #: 306547, D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, D.4. MEDICAL DEVICE LOT #: 9127846, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: COLUMBUS (WEST), G.5. PMA/510(K)#: K161552, H.4. DEVICE MANUFACTURE DATE: 2019-05-07.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE TIP BROKE OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547, BATCH NO.: 9127846. IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE INTO THE TUBING. WHEN GOING TO GIVE MEDICATION THROUGH MEDLINE. THE 0.9 NS SYRINGE WAS REMOVED FROM TUBING AND THE TIP OF THE SYRINGE WAS BROKEN OFF AND REMAINED IN THE TUBING. NEW LINE SET UP WAS MADE AND THE DEFECTIVE TUBING REMOVED AND TURNED IN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE TIP BROKE OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306547; BATCH NO.: 9127846. IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE INTO THE TUBING. WHEN GOING TO GIVE MEDICATION THROUGH MEDLINE. THE 0.9 NS SYRINGE WAS REMOVED FROM TUBING AND THE TIP OF THE SYRINGE WAS BROKEN OFF AND REMAINED IN THE TUBING. NEW LINE SET UP WAS MADE AND THE DEFECTIVE TUBING REMOVED AND TURNED IN.

    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ SYRINGE TIP BROKE OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE INTO THE TUBING. WHEN GOING TO GIVE MEDICATION THROUGH MEDLINE. THE 0.9 NS SYRINGE WAS REMOVED FROM TUBING AND THE TIP OF THE SYRINGE WAS BROKEN OFF AND REMAINED IN THE TUBING. NEW LINE SET UP WAS MADE AND THE DEFECTIVE TUBING REMOVED AND TURNED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757203 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9127846

    Patients

    Seq Age Sex Outcome Treatment
    1 Other