BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 7537514 · Received May 23, 2018

    Report

    Report Number
    9610847-2018-00146
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    May 8, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: REVIEW WAS CONDUCTED ON THE SUB-ASSEMBLY (Q-SYTE) LOT NUMBER WHICH DISCLOSED THE FOLLOWING: LOT # 7004948: SUB-ASSEMBLY LOT 6336638; REVIEW PREVIOUSLY CONDUCTED FOR PR 199699 ¿ 211451 WHICH DISCLOSED THE LOT WAS BUILT ON QFA LINE 4, FROM 03DEC2016 THRU 05DEC2016. SUB-ASSEMBLY LOT 6336634; WAS BUILT ON QFA LINE3, FROM 03DEC2016 THRU 05DEC2016 FOR THE QUANTITY OF (B)(4)EA. SUB-ASSEMBLY LOT 6348520; WAS BUILT ON QFA LINE3, FROM 13DEC2016 THRU 15DEC2016 FOR THE QUANTITY OF (B)(4)EA. ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. SET-UP AND IN-PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) BOND/WELD STRENGTH AND LEAK TESTING WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED AS IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) DATABASE REVIEW: YES. REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY. FINDINGS: THIS INCIDENT WAS AN S2 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION FOR THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS. THE REVIEWS DISCLOSED NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT. ANALYSIS OF PEURA AND/OR FMEA CONDUCTED BY QE: THE PEURA (END USER RISK ANALYSIS) RM5699 REV 5 VERSION D WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: UNIT: RECEIVED ONE Q-SYTE UNIT WITHIN A SEALED PACKAGE FROM LOT 7004948: THE PACKAGING DISPLAYED NO ANOMALIES OR DAMAGE. THE Q-SYTE WAS INTACT WITH THE BLUE DUST CAP ATTACHED. THE Q-SYTE UNIT REVEALED TO HAVE A YELLOWISH DISCOLORATION/TINT TO THE SEPTUM. NO OTHER ANOMALIES OR DAMAGE WAS OBSERVED TO THE Q-SYTE UNIT. PHOTO: A PHOTO WAS PROVIDED FOR EVALUATION OF THIS INCIDENT WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. INVESTIGATION CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE - A DEFINITE SOURCE THAT CONTRIBUTED TO THE YELLOWING DISCOLORATION OF THE SEPTUM COULD NOT BE ESTABLISHED. THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED OR SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. A SOURCE FOR THIS TYPE OF DEFECT COULD ATTRIBUTE TO THE STORAGE CONDITION OF THE END USER. COMMENT: AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND WITH FOREIGN MATTER AS "NURSE FOUND THE COLOR OF THE SEPTUM TURNED YELLOW BEFORE OPENING THE UNIT PACKAGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND WITH FOREIGN MATTER AS "NURSE FOUND THE COLOR OF THE SEPTUM TURNED YELLOW BEFORE OPENING THE UNIT PACKAGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381898 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7004948 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other