MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER; VIAL ADAPTER 20MM FLL SIL WITH 5UM FILTER - VF

Catalog Number	8072107
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is currently being investigated by manufacturer.The device has not been returned for an evaluation.However, a photograph was provided with visible primary packaging compromise of the device.Upon completion of the investigation and if additional information is provided from the manufacturer's customer a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2024, the customer, sanofi pharmaceutical contacted west pharma.Services, il ltd.(west il), to report that two (2) vial adapter 20mm w/5mic filter, lot#: h275, were rejected due to open unsealed blisters of the primary packaging.When the end user opened the kit, of the co-packaged vial adapter, lot#: h275, kitted with a medicinal product, the tyvek on the device came off the vial adapter.There was no health impact to the end user as this issue was detected prior to use.
Additional Manufacturer Narrative
A review of batch records for lot#h275 revealed no non-conformance.All qc inspections were conducted according to procedures, no other issues were identified.According to the manufacturer's records, lot#h275 was manufactured according to relevant procedures, tested before release, packed and shipped according to specifications.Complaints database of the last three years was reviewed; there were no complaints identified for this lot.15 complaints were received for catalog# 8072107, none of the complaints were determined as justified.Retained samples from lot#h275 were visually inspected, no findings were observed.The sample was returned to the manufacturer and the issue was verified.According to the sub-contractors' investigation, special instructions were written as immediate correction to avoid this issue from recurring and re-training of relevant procedures were performed.The root cause of the unsealed products is due to insufficient execution of procedure after the emergency button was pressed or the safety curtain was activated.A capa was opened by the contract manufacturer to address the issue including holding awareness training and training on the special instruction.The capa is closed with corrective actions and effective check was verified.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER 20MM FLL SIL WITH 5UM FILTER - VF
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 20561885
• Report Number: 3000223297-2024-00007
• Device Sequence Number: 3162841
• Product Code: LHI
• UDI-Device Identifier: 07290108240184
• UDI-Public: (01)07290108240184(17)280101(10)H275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 8072107
• Device Lot Number: H275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown