MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD. MIX2VIAL TRANSFER DEVICE

Catalog Number	8074001
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	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 15nov2024, the customer, pfizer inc.Contacted the manufacturer to report that one (1) box containing a shipment of 300 mix2vial transfer devices, lot# j966, was delivered damaged, exposing the devices inside the box and breaching sterility of the devices.There was no health impact to the end user as this issue was detected prior to use.
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 damage to the shipping box.Upon completion of the investigation and if additional information is provided from the manufacturer's customer a follow-up report will be submitted.
Additional Manufacturer Narrative
A review of batch records for lot# j966 revealed no non-conformance.All qc inspections were conducted according to procedures, no other issues were identified.According to the manufacturer's records, lot# j966 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 complaint were found for this lot.Retained samples from lot#h275 were visually inspected, no findings were observed.According to the the sub-manufacturer's review, no issues were noticed for this lot.There is no clear evidence that the product has breach in sterility as the samples were not returned to the manufacturer for an evaluation.The most probable root cause of the damaged shipping box is due to is mishandling during storage or transportation.There is no indication that the damage was the responsibility of the manufacturer as the shipping vendor signed off on the released the goods without any damage.Therefore, no further action is required.

• Brand Name: MIX2VIAL TRANSFER DEVICE
• Common Device Name: MIX2VIAL TRANSFER DEVICE
• 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: 20919007
• Report Number: 3000223297-2024-00010
• Device Sequence Number: 20110695
• Product Code: LHI
• UDI-Device Identifier: 07290108240672
• UDI-Public: (01)07290108240672(17)290930(10)J966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031861
• 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): 03/26/2025

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: 8074001
• Device Lot Number: J966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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