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

Catalog Number 900165

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Event 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.

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.

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.

• Brand Name: MIX2VIAL TRANSFER DEVICE
• Type of Device: 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
• MDR Text Key: 328012463
• Report Number: 3000223297-2023-00017
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240801
• UDI-Public: 07290108240801
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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
• Device Operator: Other
• Device Catalogue Number: 900165
• Device Lot Number: H489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1