BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER 13MM FLL SIL - VF

    MDR report key: 23778679 · Received December 11, 2025

    Report

    Report Number
    3000223297-2025-00007
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    September 1, 2025
    Report Date
    March 11, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    UDI-DI
    07290108240078
    PMA / PMN Number
    K001293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    BATCH RECORD REVIEW: A BATCH RECORD REVIEW WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. IT WAS CONFIRMED THAT ALL QC INSPECTIONS WERE CONDUCTED DURING PRODUCTION AND ACCORDING TO THE APPLICABLE PROCEDURES. PER THE PRODUCTION RECORDS, LOT H556 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. RETAINED SAMPLES: RETAINED SAMPLES FROM LOT H556 WERE 200% VISUALLY INSPECTED BY THE SUB-CONTRACTOR WITH NO FINDINGS OBSERVED. SAMPLE ANALYSIS: AN EVALUATION WAS PERFORMED ON RETAINED SAMPLES OF LOT H556, INCLUDING PACKAGING INTEGRITY TESTING. THE PACKAGE INTEGRITY STUDY INCLUDED THE FOLLOWING TESTS: VISUAL INSPECTION OF PRIMARY PACKAGE. STERILE BARRIER VISUAL INSPECTION. BUBBLE EMISSION. ALL FIVE TESTED RETAINED SAMPLES MET THE ACCEPTANCE CRITERIA AND PASSED THE TESTS. NO CONDITIONS MEETING THE FAILURE CRITERIA WERE OBSERVED DURING TESTING. THE TEST RESULTS CONFIRMED THAT THE SAMPLES WERE INTACT AND FUNCTIONING PROPERLY, AND NO DEVIATIONS ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. TRANSPORTATION ASSESSMENT: EXTENSIVE TRANSPORTATION TESTING WAS PERFORMED AS PART OF THE VERIFICATION TESTING, INCLUDING IMPACT AND VIBRATION TESTING ON PALLETIZED LOADS. ACCORDING TO THIS ASSESSMENT, THE RISK OF TYVEK PUNCTURE OCCURRING DURING STANDARD PRODUCT TRANSPORTATION IS CONSIDERED LOW, AND IT IS THEREFORE UNLIKELY THAT THE REPORTED FAILURE OCCURRED DURING SHIPPING. RISK ASSESSMENT: ACCORDING TO THE COMPLAINT DESCRIPTION, AND BASED ON PACKAGING VALIDATION AND SHIPPING TESTS, TOGETHER WITH EXAMINATION OF THE SAMPLES ACQUIRED AND PACKAGE INTEGRITY TESTING, IT IS MOST LIKELY THAT PUNCTURE OF THE TYVEK® WAS MADE DURING THE OPENING OF THE PACKAGE. AS THE OBSERVED PUNCTURE OCCURRED AT THE MOMENT THE TYVEK® COVER WAS BEING OPENED, MEANING THE STERILE BARRIER WAS ONLY BRIEFLY COMPROMISED. BECAUSE THE BREACH HAPPENED DURING THE ACT OF OPENING - IMMEDIATELY PRIOR TO INTENDED USE - THE EXPOSURE TIME WAS EXTREMELY LIMITED, AND THERE WAS MINIMAL OPPORTUNITY FOR ENVIRONMENTAL CONTAMINANTS TO ENTER OR PROLIFERATE. AS A RESULT, THE POTENTIAL LOSS OF STERILITY IS CONSIDERED LOW IN SEVERITY, SINCE THE EVENT DID NOT ALLOW SUFFICIENT TIME OR CONDITIONS FOR SIGNIFICANT CONTAMINATION TO OCCUR. OVERALL RISK REMAINS ACCEPTABLE AND ADEQUATELY CONTROLLED BY EXISTING MEASURES. CLINICAL ASSESSMENT: BECAUSE THE BREACH OF THE STERILE BARRIER APPEARS TO HAVE OCCURRED IN VERY CLOSE TEMPORAL PROXIMITY TO THE INTENDED OPENING OF THE PACKAGE, THE POTENTIAL WINDOW DURING WHICH THE STERILE CONTENTS COULD HAVE BEEN EXPOSED TO THE EXTERNAL ENVIRONMENT WAS EXTREMELY LIMITED. IN TYPICAL CLINICAL SETTINGS, THE RISK OF MICROBIAL INGRESS IS CLOSELY RELATED TO BOTH THE DURATION AND THE CONDITIONS OF EXPOSURE. A MOMENTARY OR NEAR-IMMEDIATE BREACH AT THE TIME OF OPENING PROVIDES INSUFFICIENT OPPORTUNITY FOR CLINICALLY MEANINGFUL CONTAMINATION. UNDER SUCH CIRCUMSTANCES, THE PROBABILITY OF VIABLE MICROORGANISM TRANSFER, SUBSEQUENT CONTAMINATION, OR PROLIFERATION ON THE STERILE DEVICE IS CONSIDERED LOW. IMPORTANTLY, NO ADVERSE EVENTS, PATIENT INJURIES, POST-PROCEDURAL COMPLICATIONS, OR CLINICAL OUTCOMES SUGGESTIVE OF INFECTION OR INFLAMMATION WERE REPORTED IN CONNECTION WITH THIS COMPLAINT. THE ABSENCE OF INFECTION-RELATED SEQUELAE FURTHER SUPPORTS THE ASSESSMENT THAT ANY POTENTIAL LOSS OF STERILITY DID NOT TRANSLATE INTO MEASURABLE CLINICAL HARM. BASED ON THE TOTALITY OF EVIDENCE, THE POTENTIAL LOSS OF STERILITY ASSOCIATED WITH THE OBSERVED PUNCTURE IS NOT EXPECTED TO CONTRIBUTE TO MEANINGFUL PATIENT RISK. THE CLINICAL RISK ASSOCIATED WITH THIS COMPLAINT REMAINS LOW AND IS ALIGNED WITH THE PREVIOUSLY ASSIGNED SEVERITY RATING. NO FURTHER CLINICAL ACTION IS WARRANTED AT THIS TIME, AND THE EVENT DOES NOT INDICATE A NEW OR EMERGING SAFETY SIGNAL. ROOT CAUSE: BASED ON ALL AVAILABLE EVIDENCE INCLUDING EVALUATION OF RETAINED SAMPLES, PACKAGE-INTEGRITY TESTING, AND REVIEW OF MANUFACTURING AND INSPECTION RECORDS NO DESIGN, PROCESS, OR MANUFACTURING DEFICIENCIES WERE IDENTIFIED THAT COULD EXPLAIN A TYVEK® PUNCTURE ORIGINATING DURING PRODUCTION OR DISTRIBUTION. ALL TESTED UNITS MET THE REQUIRED ACCEPTANCE CRITERIA. BECAUSE NO CUSTOMER SAMPLE WAS RETURNED, DIRECT CONFIRMATION OF THE REPORTED UNIT WAS NOT POSSIBLE. HOWEVER, THE EVIDENCE STRONGLY SUPPORTS THAT THE PUNCTURE MOST LIKELY OCCURRED DURING OPENING, DUE TO CUSTOMER MISUSE, WHERE LOCALIZED MECHANICAL FORCE WAS APPLIED ON THE TYVEK® ABOVE THE SPIKE, CAUSING IT TO DEFORM INWARD AND PUNCTURE.

    Description of Event or Problem · 0

    THE MANUFACTURER'S PHARMACEUTICAL CUSTOMER, AMGEN, CONTACTED THE DEVICE MANUFACTURER ON 15NOV2025 TO REPORT THAT DURING THE PROPER OPENING OF THE VIAL ADAPTER'S OUTER PLASTIC PACKAGING, IT WAS NOTICED THAT THE SEALING COVER FOIL HAD ALREADY BEEN PIERCED BEFORE BEING PEELED OFF. IT IS CURRENTLY NOT KNOWN WHETHER THE PIERCED SEALING COVER BREACHED THE STERILITY OF THE PRIMARY PACKAGING AND THIS CONFIRMATION OF THIS HAS BEEN REQUESTED. AS THE AFFECTED DEVICE WAS NOT USED BY THE PATIENT, THERE WAS NO HEALTH IMPACT TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493197 VIAL ADAPTER 13MM FLL SIL - VF VIAL ADAPTER 13MM FLL SIL - VF LHI WEST PHARMA. SERVICES IL, LTD. H556 07290108240078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown