BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7273523 · Received February 15, 2018

    Report

    Report Number
    9610847-2018-00026
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 23, 2018
    Report Date
    March 23, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. UPON EXAMINATION, THE Q-SYTE WAS OBSERVED SEPARATED AT THE TOP BODY AND BOTTOM BODY AND A TEAR WAS OBSERVED AT THE SLIT OF THE SEPTUM. FURTHER EXAMINATION OF THE PRODUCT SHOWED EVIDENCE OF AN ADEQUATE WELD LINE BETWEEN THE TOP AND BOTTOM BODY, INDICATING SUFFICIENT BOND AT THE TIME OF MANUFACTURE. A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR AT THE SEPTUM COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE. 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 OBSERVED DEFECTS. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHRS ARE AVAILABLE FOR REVIEW AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. FINDINGS: MDR: REVIEW WAS CONDUCTED ON THE SUB-ASSEMBLY (Q-SYTE) LOT NUMBERS WHICH DISCLOSED THE FOLLOWING: LOT #7235538: SUB-ASSEMBLY LOT 7220530; WAS BUILT ON QFA LINE3, FROM 10AIG2017 THRU 11AUG2017 FOR THE QUANTITY OF (B)(4). SUB-ASSEMBLY LOT 7220533; WAS BUILT ON QFA LINE 3, FROM 13AUG2017 THRU 17AUG2017 FOR THE QUANTITY OF (B)(4). PER REVIEW OF THE DHRS IT WAS CONCLUDED THAT 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 THESE LOTS 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. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE Q-SYTE UNIT ACCOMPANIED BY AN OPENED PACKAGE FROM LOT 7233538. THE UNIT WAS RECEIVED IN 2 PORTIONS; TOP BODY AND BOTTOM BODY. VISUAL/MICROSCOPIC EXAMINATION: THE Q-SYTE WERE SEPARATED AT TOP BODY AND BOTTOM BODY (POLYCARBONATE). CONFIRMED THERE WAS THERE WAS EVIDENCE OF AN ADEQUATE WELD LINE BETWEEN THE TOP AND BOTTOM BODY (POLYCARBONATE); INDICATING A SUFFICIENT BOND AT TIME OF MANUFACTURE. OBSERVED THE SLIT WAS CENTERED IN ITS CORRECT POSITION ON THE SEPTUM TOP DISK. THERE WAS A TEAR AT ONE END OF THE SLIT. SEPTUM COLUMN TEAR ASSESSMENT: THERE WERE NO TEARS TO THE COLUMN WALL OF THE UNIT. BOTTOM SEPTUM EVALUATION: OBSERVED THE SLIT AT THE SEPTUM BOTTOM DISK WAS IN ITS¿ CORRECT POSITION (CENTERED) AND THERE WAS A TEAR AT EACH END OF THE SLIT. NO FURTHER ANOMALIES OR DAMAGE WAS OBSERVED ON THE EXTERNAL AREAS OF THE RETURNED Q-SYTE UNIT. THE FINDINGS IN THIS INCIDENT WERE INDICATIVE THAT THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS FOR THE FAILURE. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO; THE Q-SYTE WAS OBSERVED TO HAVE A TEAR AT ONE/BOTH END(S) OF THE SLIT AT THE SEPTUM TOP AND/OR BOTTOM DISK. ALTHOUGH THE Q-SYTE TOP BODY AND BOTTOM BODY WERE SEPARATED FROM EACH OTHER; THERE WAS EVIDENCE OF SUFFICIENT BOND (WELD) AT THE TIME OF MANUFACTURE. CONCLUSIONS: CONFIRMATION OF THE FAILURES OF LEAKAGE AS STATED IN THE PRODUCT INCIDENT REPORT WAS CONCLUSIVE WITH THE USED UNIT RECEIVED FOR THIS INCIDENT. CONFIRMED TOP BODY AND BOTTOM BODY WERE SEPARATED FROM EACH OTHER. CONFIRMED THERE WAS NO DAMAGE TO THE TOP OR BOTTOM BODY (POLYCARBONATE) OF THE Q-SYTE. CONFIRMED THERE WAS EVIDENCE OF AN ADEQUATE WELD BETWEEN THE TOP AND BOTTOM BODY (POLYCARBONATE); INDICATING A SUFFICIENT BOND AT TIME OF MANUFACTURE. NOTE THAT THE SEPARATION OF THE TOP AND BOTTOM BODY COULD RESULT IN LEAKAGE IN THE CLINICAL ENVIRONMENT. INVESTIGATION CONCLUSION: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE THE LOCATION WHERE THE TOP AND BOTTOM BODY WERE SEPARATED REVEALED EVIDENCE OF AN ADEQUATE WELD. THIS IS AN INDICATION THAT A BOND (WELD) WAS PROVIDED DURING THE MANUFACTURING PROCESS. A FAILURE MODE ASSOCIATED WITH THE RETURNED SAMPLE DID NOT INDICATE THAT MANUFACTURING PROCESS INTRODUCED THE DAMAGE OBSERVED. EXTERNAL FORCES MOST LIKELY CONTRIBUTED TO THE DAMAGE OBSERVED. A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR(S) AT THE END OF THE SLIT OF THE SEPTUM TOP/BOTTOM DISK COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE. IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO IDENTIFY PROCESS CHANGES THAT COULD CONTRIBUTE DAMAGE AND/OR ADVERSELY AFFECT PRODUCT PERFORMANCE. COMMENT: AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY. CORRECTIONS AND CAPA: CORRECTIVE ACTION PROJECT / CAPA (#): A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. 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. OTHER ACTION TAKEN: Q-SYTE PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND PROCESS CONTROL TECHNICIANS TO ENSURE PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    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 A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118720 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7235538 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other