BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTROSYTE-N¿ PRECISION INTRODUCER

    MDR report key: 7388590 · Received April 2, 2018

    Report

    Report Number
    1710034-2018-00124
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 9, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    DYB
    UDI-DI
    50382903840217
    PMA / PMN Number
    K020834
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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. DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: MDR: REVIEW WAS CONDUCTED WHICH DISCLOSED THE FOLLOWING. SUB-ASSEMBLY P/N Y2566AAL: LOT 4267836; WAS BUILT ON 05SEPT2014 THROUGH 15NOV2014 FOR THE QTY. OF 20,000 EA. LOT 4300583; WAS BUILT ON 04NOV2014 THROUGH 17NOV2014 THE QTY. OF 10,178EA. LOT 4352925; WAS BUILT ON 18DEC2014 THROUGH 15JAN2015 FOR THE QTY. OF 15,000EA. PACKAGED LOT: P/N NSZ0384021AAL LOT 5002761; WAS PACKAGED FROM 26JAN2015 THROUGH 28JAN2015 (QTY. 28,800EA) AND CONTAINED UNITS FROM EACH SUB-ASSEMBLY LOT NOTED ABOVE. THE PEURA (END USER RISK ANALYSIS) RM5863 REV 4.0 WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, AND LOW SEVERITY CURRENT RISK IS ACCEPTABLE. ALL REQUIRED SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. REVIEWS DISCLOSED NO INDICATION OF THE ALLEGED DEFECT AS THERE WERE NO RELATED REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. CONFIRMATION OF THE DEFECT STATED IN THE SUBJECT OF THE PR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECTS STATED IN THE PR. THE ROOT CAUSE OF THIS INCIDENT IS INDETERMINATE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A BD INTROSYTE-N¿ PRECISION INTRODUCER DETACHED FROM THE HUB. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233808 BD INTROSYTE-N¿ PRECISION INTRODUCER CATHETER INTRODUCER DYB BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5002761 50382903840217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other