MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD MP VIAL ADAPTER 13MM

Catalog Number	8070142
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the customer ferring production inc.Us, contacted west pharma.Services, il ltd.(west il), to report that upon quality control, 13 boxes of the mp vial adapter 13mm, lot j075, were found to have damaged primary packaging on all inspected samples.The event was discovered prior to patient use.
Additional Manufacturer Narrative
West il is currently investigating this complaint.The device has not been returned to west il for an evaluation.However, a photograph was provided to west il which shows the deformed products as reported.Upon completion of the west il investigation and if additional information is provided from the customer, a follow up report will be submitted.
Additional Manufacturer Narrative
West pharma services il (west il) investigated a complaint received by ferring production inc.Us, regarding 13 boxes of the mp vial adapter 13mm sil fll - vf, lot j075, found to have damaged primary packaging on all inspected samples.The returned samples were received at west il, on (b)(6) 2023, and were inspected.Five products were detected in the q-cap box with deformed blisters, and 2 products out of 5 were detected to have blisters that were opened.According to the customer, multiple boxes were reviewed and similar issue were found in different shipper boxes.West il performed an investigation to include both outer and individual catalog and lot numbers of the mp vial adapter 13mm fll- vf.Mp vial adapter 13mm fll- vf 5 pack q-cap, cat#8070150, lot#j073 (outer packaging manufacturing date:(b)(6) 2023) and mp vial adapter 13mm fll - vf, cat# 8070142, lot#j075 (individual packaging).Catalog# 8070150 lot# j073 is packaged for the customer, ferring production inc.Us.According to west il records, lot#j073 was manufactured according to relevant procedures, tested before release, packed, and shipped according to specifications.An official supplier complaint was sent to the contract manufacturer 3by with a request for investigation.According to the contract manufacturer 3by report, no issues were found with their packaging and inspection process.An official supplier complaint was then sent to the shipping vendor, dhl with a request for investigation.According to the contract manufacturer dhl report, although external damage to the shipment is not an indication for high temp exposure, the temperature may not affect the packaging, but can affect the products sealing in case of exposure to temperature above 70°c which may lead to blister deformation and/or damaged sealing.The returned samples were received at west il, on (b)(6) 2023, and were inspected.Five products were detected in q-cap box with deformed blisters and 2 products out of 5 were detected to have blisters that were opened.Retained samples were visually inspected for both lots j075 and j073 and no issues were noticed.According to available data, it is most likely that lot#j075 was not exposed to high temperature during device manufacture or sterilization.Hence, lot#j075 was most likely exposed to high temperature during shipment of lot #j073 which is the responsibility of west il until the shipment arrives to the customer.The shipping vendor has no specifications for storage and shipping conditions, only to "ship and store at room temperature, protect from sun light." therefore, the root cause of this event, is due to insufficient definition for storage and shipping conditions of the final goods under west il responsibility.In addition, no current control exists for the requirement to "avoid direct sun light" during storage, shipment, and transportation of the packed products before sterilization and for final goods.West il has initiated a corrective action to address appropriate storage and shipping conditions definition for packed products before sterilization and for final goods.

• Brand Name: MP VIAL ADAPTER 13MM
• Common Device Name: MP VIAL ADAPTER 13MM
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf st.; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf st.; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west dr; exton, PA 19341 ; 4848853298
• MDR Report Key: 17663873
• Report Number: 3000223297-2023-00014
• Device Sequence Number: 7124013
• Product Code: LHI
• UDI-Device Identifier: 07290108240139
• UDI-Public: 07290108240139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 8070142
• Device Lot Number: J075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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