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

Catalog Number	900165
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10oct2023, the customer, csl behring, contacted west pharma.Services, il ltd.(west il), to report that during packaging of the mix2vial transfer device, lot h489 which was to be packed with a csl product lot, operators identified more than one hundred mix2vial devices with deformed and/or opened blisters.Csl behring performed an investigation on this event.Per the customer, it was concluded that one or more pallets of the mix2vial were likely exposed to a strong heat source as the temperature labels on the shipping pallets had switched from silver to black.This is an indication that the pallets were exposed to a temperature of 71 degrees celsius or higher.The affected lot h489 was sent by plane.
Additional Manufacturer Narrative
West pharma.Services il, ltd.(west israel) is currently investigating this complaint.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
A preliminary investigation was performed by west il.According to west il records, lot# h489 was manufactured according to relevant procedures, tested before release and shipped according to specifications.The lot was sealed by an automatic sealing machine mp-405.Batch records for lot# h489 were reviewed and there were no non conformances found.Quality control inspections were conducted according to the procedures, no issues were noticed.Retained samples from lot# h489 were 100% inspected by the sub-contractor, no issues were observed.The returned samples were received at west il, on 13-nov-2023 and were inspected.From the returned samples, some of the products were observed with opened and deformed blisters and some of the products were observed with blisters that were slightly deformed but not opened.An official supplier complaint was sent to the shipping vendor with a request for investigation.However, no reply has been received from the shipping vendor.It was decided to return the lot to west il and perform the 100% sorting for further investigation of this issue.The return process has been initiated and is currently ongoing.A follow up report will be submitted if additional information is received and or upon completion of this investigation.
Additional Manufacturer Narrative
Unique device identifier (udi) # corrected.Complaint is currently being investigated by manufacturer.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#h489 revealed no non-conformances.All qc inspections were conducted according to procedures, no other issues were identified.According to our records, lot#h489 was manufactured according to relevant procedures, tested before release, packed and shipped according to specifications.Complaints database of the last three years were reviewed; three justified complaints were found for this product catalog number, 900165, regarding this reported issue.No complaints were found related to lot#h489.Retained samples from lot#h489 were 100% visually inspected by the contract manufacturer - no findings were observed.The returned samples were received at the manufacturer on 13-nov-2023 and were inspected.The reported issue was verified.A supplier complaint was sent to the contract manufacturer to investigate this issue.According to the contract manufacturer's investigation, the requirements for this shipment did not include any temperature controls.Therefore, the contract manufacturer could not indicate the specific time the deviation occurred.According to available data, it is most likely that lot#h489 was not exposed to high temperatures during device manufacture or sterilization.Hence, lot#h489 was likely exposed to high temperatures during shipment which is the responsibility of the manufacturer until the shipment arrives to the customer.A corrective action was initiated by the manufacturer to address appropriate definitions of storage and shipping conditions for final goods.

• Brand Name: MIX2VIAL TRANSFER DEVICE
• Common Device Name: MIX2VIAL
• 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: 18095812
• Report Number: 3000223297-2023-00017
• Device Sequence Number: 20304451
• Product Code: LHI
• UDI-Device Identifier: 07290108240801
• UDI-Public: (01)07290108240801(17)280201(10)H489
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2025

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: 900165
• Device Lot Number: H489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/17/2024; Not provided; 12/30/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/15/2024; 10/17/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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