MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER 13MM FLL SIL - VF

Catalog Number	8070117
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01sep2023, the customer, sharp clinical services llc, contacted west pharma.Services, il ltd.(west il), to report that during reconstitution of a medication (sotatercept 60mg open label patient kits) to be administered subcutaneously, a gray particle was observed within the solution that could not be dissolved.As per photo provided, the customer could not precisely provide the dimensions of the particle, stated "perhaps 1-2mm".The vial adapter, along with the medication and diluent, were inspected before preparation started and there were no issues observed.A replacement product was prepared and administered.
Additional Manufacturer Narrative
West pharma services il (west il) investigated a complaint received by sharp clinical services llc regarding a foreign particle observed within a vial of the reconstituted solution which could not be dissolved.The product was not returned to west il for evaluation.However, a photograph was provided to west il with a visible particle as reported inside of the vial.According to batch records review on lot number f547, it was manufactured according to relevant procedures, tested before release and shipped according to specifications.There were no related non-conformances found and no findings were observed.Additionally, no deviations in the production process were found.Retained samples from lot #f547 were visually inspected by the sub-contractor and no findings were observed.According to the customer, no samples are available for investigation.The described particle could not pass through the spike, since the dimensions of the particle reported as approximately 1-2mm, while the spike tip of the vial adapter has 3 windows and each window is 0.5mm.At this time, the root cause could not be determined.

• Brand Name: VIAL ADAPTER 13MM FLL SIL - VF
• Common Device Name: VIAL ADAPTER
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana 43664
• 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: 17843568
• Report Number: 3000223297-2023-00016
• Device Sequence Number: 11862502
• Product Code: LHI
• UDI-Device Identifier: 07290108240078
• UDI-Public: 07290108240078
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Foreign,Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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: Health Professional
• Device Catalogue Number: 8070117
• Device Lot Number: F547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2022
• 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