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

Model Number	8074022
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 17-feb-2022, the west's customer, takeda pharmaceutical company limited, contacted west il to report that during incoming inspection of mix2vial 20/20mm w/20 m large filter tg, the visual inspection found one unit containing a foreign material within the blister package of the device. west pharma.Services il, ltd.(west israel)  investigated this complaint.  the device was not returned to west il for an evaluation.  however, a photograph of the device was provided to west il.  the foreign material within the blister package was analyzed by the customer and confirmed as hair (biologic) which was in direct contact with the west il product.  this was found prior to patient use.  the complaint was re-evaluated and deemed as reportable based on a clinical assessment on 23mar2023.
Additional Manufacturer Narrative
According to obtained picture , the reported issue was verified.During in process as 700 products were visually tested, no issues were noticed, in addition a total of 1785 products were tested during  in process with no issues  noticed.  the biological contamination (hair)  was a result of employees, clothes or from the raw material such as blister and tyvek suppliers or molded parts, and human factor in production during the assembly or the sealing process.   .

• Brand Name: MIX2VIAL TRANSFER DEVICE
• Common Device Name: MIX2VIAL TRANSFER DEVICE
• 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 drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 16784659
• Report Number: 3000223297-2023-00004
• Device Sequence Number: 5522878
• Product Code: LHI
• UDI-Device Identifier: 07290108240429
• UDI-Public: 07290108240429
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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 Expiration Date: 07/01/2025
• Device Model Number: 8074022
• Device Catalogue Number: 8074022
• Device Lot Number: E290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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