MAUDE Adverse Event Report: WEST PHARNA. SERVICES IL, LTD VIAL ADAPTER 20MM FLL-VF UNIVERSAL

Model Number 8072003

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

The customer, pacira biosciences, inc., initially contacted west il on 09jun2023 to report that four patients developed infections post injection of the medication zilretta, to the knee joint.Subsequently, the customer reported an additional two patients on (b)(6) 2023 who also developed infections post injection of the medication zilretta, to the knee joint.Therefore, a total of six patients were reported.There were three different healthcare facilities involved in all six events.The facility where this event took place was in missouri, united states of america.However, the name of the facility was not provided.The date of event and the onset of infection is unknown for this incident.This report is for patient two of six.Zilretta is a single dose medication packaged as a kit with the west il vial adapter 20mm fll -vf universal.Per the customer, all kits used on the six patients who developed infections, contained the same west il vial adapter (lot# e891).However, these kits are packaged with the zilretta medication and a diluent.The drug product and diluent are of different lots.There was no report of breach in sterility and the injection was administered uneventfully.The patient was treated for the infection and was reported to be responding well to treatment.

Manufacturer Narrative

West pharma.Services il, ltd.(west israel) is investigating this complaint.Preliminary findings revealed that all six complaints are related to the same vial adapter lot, as the entire lot of vial adapter 20mm fll -vf universal e891, was shipped to the customer.According to production review records, lot# e891 was manufactured per procedure, tested prior to release and shipped according to specifications.Batch records review was performed with no non-conformances detected.Quality control inspections including visual, in-process and final inspection revealed no identified deviations for this lot during production and packaging.Ninety (90) retained samples of lot # e891 had no particles observed in all of the samples.According to west il records, lot# e891 was sterilized by validated gamma irradiation and met the sterilization criteria and the endotoxin test (lal) also met the acceptance criteria.Additionally, a review of the complaints database found no similar complaints for this issue and therefore no trend.The customer received two (2) kits that were returned from one of the three sites where the infections were reported.The two kits contain one vial adapter in each kit of lot e891.However, the customer sent only one (1) unopened vial adapter to west il which was received on 26jun2023 and is currently being evaluated.The device used in the reported event was not returned.Upon completion of the west il investigation and if additional information is provided from the customer a follow up report will be submitted.Related report number(s): 3000223297-2023-00005, 3000223297-2023-00007, 3000223297-2023-00008, 3000223297-2023-00009, 3000223297-2023-00010.

Manufacturer Narrative

On 26-june-2023, an unopened and unused customer sample from the reported lot of the vial adapter 20mm fll -vf universal was received at west il.However, at this time, west il will not conduct additional testing on the sample provided by the customer pacira, due to possible destruction during the testing process.As previously established, there is no concern raised regarding the validity of the final product sterilization process.Nonetheless, west il will retain the sample provided by the customer, pacira.There is no indication that the vial adapter 20mm has a correlation between infection of the patient.According to the available information, the root cause for the reported complaint could not be precisely determined.

• Brand Name: VIAL ADAPTER 20MM FLL-VF UNIVERSAL
• Type of Device: VIAL ADAPTER 20MM FLL-VF UNIVERSAL
• Manufacturer (Section D): WEST PHARNA. SERVICES IL, LTD; 4 hasheizaf st; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf st; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 17269351
• MDR Text Key: 318545389
• Report Number: 3000223297-2023-00006
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8072003
• Device Catalogue Number: 8072003
• Device Lot Number: E891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2021
• 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
• Patient Outcome(s): Other; Required Intervention