MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER; VIAL ADAPTER 20MM FLL SIL

Catalog Number	8072031
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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 07nov2024, the customer, baxter healthcare corporation, contacted the manufacturer to report that vial adapter 20mm in the boxes on top of the pallets appear to have been deformed under high temperatures.The boxes also appear to have some parts discolored, probably due to high temperatures.11 of the 12 shipper boxes on top of the pallets have damaged vial adapter 20mm.Please note that the shipper boxes did not appear to have any form of damaged that could be attributed to physical damage.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# k520 revealed no non-conformance.All qc inspections were conducted according to procedures, no other issues were identified.According to the manufacturer's records, lot#k520 was manufactured according to relevant procedures, tested before release, packed and shipped according to specifications.Complaints database of the last three years was reviewed; no justified complaints were identified for this lot.Samples from lot#k520 were 100% visually inspected twice during the production - no findings were observed.According to the sub-contractors' review of sterilization records, no issues were noticed for lot#k520.No samples were returned to the manufacturer.However, per the obtained pictures, products were detected with deformed and open blisters, the reported issue was verified.According to available data, it is likely that lot#k520 was not exposed to high temperatures during the manufacturing or sterilization process.The manufacturer is unable to fully monitor the conditions the products are exposed to while under service providers such as couriers and transportation contractors.Hence, this issue likely occurred during shipment of lot#k520.This is due to insufficient temperature monitoring over the door to door shipment process, which is the manufacturer's responsibility.Corrective and preventative action was initiated to address appropriate storage and shipping conditions definition for final goods.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER 20MM FLL SIL
• 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: 20843637
• Report Number: 3000223297-2024-00009
• Device Sequence Number: 3928372
• Product Code: LHI
• UDI-Device Identifier: 07290108240597
• UDI-Public: (01)07290108240597(17)290630(10)K520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 8072031
• Device Lot Number: K520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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