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

Catalog Number 8070117

Device Problem Contamination (1120)

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

Event Date 08/29/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324589201
• Report Number: 3000223297-2023-00016
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240078
• UDI-Public: 07290108240078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 8070117
• Device Lot Number: F547
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2022
• 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