MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER 13MM LONG W/25MIC FILTER-VF

Catalog Number	8070201
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the customer, novo nordisk, contacted west pharma.Services, il ltd.(west il), to report that during quality control of lot f759, one (1) retention sample of the vial adapter 13 mm, was found to have visible black particles within the seal of the packaging and also on the inside of the packaged device.The event was discovered prior to patient use.
Additional Manufacturer Narrative
West pharma.Services il, ltd.(west il) is currently investigating this complaint.The device will not be returned to west il for an evaluation.However, a photograph was provided to west il with visible particles as reported inside of the packaged device.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
West pharma services il (west il) investigated a complaint received by novo nordisk, regarding observed black particles within the seal of the packaged vial adapter 13mm.The affected sample was not returned to west il for evaluation, therefore, the nature of the particle could not be determined.According to a photo provided by the customer, the reported particle does not cross the sealing area and no particles were observed inside the blister pack.Batch records review was performed on lot number f759 and no issues were noticed.This lot was manufactured according to relevant procedures, tested before release, and shipped according to specifications.Retained samples of lot number f759 were visually inspected no issues were noticed.West il sent a formal request for investigation to the sub-contractor.According to the sub-contractor, retained samples from lot#f759 were 100% visually inspected, no findings were observed.As the sample was not sent by the customer to west il, the complaint subject could not be fully investigated.Therefore, according to available information, the probable root cause could not be determined.

• Brand Name: VIAL ADAPTER 13MM LONG W/25MIC FILTER-VF
• Common Device Name: VIAL ADAPTER
• 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 dr; exton, PA 19341 ; 4848853298
• MDR Report Key: 17817781
• Report Number: 3000223297-2023-00015
• Device Sequence Number: 17693509
• Product Code: LHI
• UDI-Device Identifier: 07290108240245
• UDI-Public: 07290108240245
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K963583
• 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
• Report Date (Section B): 12/12/2023

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 Catalogue Number: 8070201
• Device Lot Number: F759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 11/19/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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