MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD MIXJECT 20MM W/20G X 1.5'' NEEDLE

Model Number	9070103
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
West il is currently investigating this complaint.The device has not yet been returned to west il for an evaluation.However, a photograph was provided to west il by the customer with a visible particle 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.
Event or Problem Description
The customer, gp pharm, contacted west pharma.Services, il ltd.(west il) on 22jun2023 to report that during packaging and quality control of batch 230173, lot f967, one unit of the mixject 20mm w/20g x 1.5" needle was found with a particle inside of the packaged device.The event was discovered prior to patient use.
Additional Manufacturer Narrative
On (b)(6) 2023, the customer, gp pharm., contacted west pharma.Services, il ltd.(west il) with additional information.It was reported that during packaging and quality control of the mixject 20mm w/20g x 1.5" needle, lot f967, two additional units were found with foreign material inside the sealed and packaged products.West il, is currently investigating this complaint.The devices have not yet been returned to west il for evaluation.However, photographs were provided to west il with visible foreign material as reported inside of the packaged devices.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
A preliminary investigation was performed by west il.According to production records review, lot# f967 was manufactured according to relevant procedures, tested before release, shipped according to specifications, and sealed by a nelipak sealing machine.Batch record for lot# f967 was reviewed and no ncm's were found.All qc inspections were conducted according to procedures during production, no issues were noticed.The incoming inspection records of the tyvek and blister used for the manufacturing of lot# f967 were reviewed, no issues were noticed.The incoming inspection records of the needles used for the manufacturing of lot f967 were reviewed.No ncm were noticed related to the reported issue and no other issues were noticed.Three samples were returned and received at west il and were inspected.In a visual inspection, the first sample had a free particle was observed inside the blister.The second sample, a fiber was noticed over the cannula.The third sample, a particle was noticed over the cannula.An official supplier complaint was sent to the contract manufacturer with a request for an investigation on the sample with the yellow particle.According to the contract manufacturer preliminary investigation, batch records were reviewed for this lot, during the manufacturing process 5,250 products were inspected, no products were found with any foreign particles.For the final inspection, 5,075 products were inspected, and none were found with any foreign particles.This lot was sealed on a semi-automatic nelipak sealing machine, while the blister with the product and the tyvek are manually placed in this machine for the sealing process.According to the characteristics of the yellow particle inspected by an ogp magnification x80, the particle was identified as a part of the plastic needle hub.Regarding the two additional samples with foreign matter seen on the cannula, an official supplier complaint was sent to the needle supplier.According to the needle supplier report, production records were reviewed, no deviation was indicated.Retained samples were checked, and no deviations were found.A follow up report will be submitted upon receipt of the finalized reports including samples analysis from both suppliers.
Additional Manufacturer Narrative
Retained samples from lot#: f967 were 100% inspected by the contract manufacturer, no issues were observed.An official supplier complaint was sent to the contract manufacturer.According to the contract manufacturer's investigation, one product was observed with a yellow free particle inside of the product blisters.It is most likely that the free particle was adhered to the opened product during the manual operation at the sealing station, or it was adhered from one of the supplied the raw materials.Regarding the two products with foreign matter on the cannula, the most probable root cause was due to insufficient process and procedure to avoid foreign material adhering to the product.Additionally, the returned samples were tested to identify the foreign materials.According to the test results, one material was identified as polypropylene, and the second material was identified as silicon rubber.Corrective actions were issued by the contract manufacturer and the needle supplier to update their procedures in effort to reduce environmental exposure to the products.No other similar justified complaints were found.Device manufacturing date updated to 12dec2022.No further corrective action is required by west il.

• Brand Name: MIXJECT 20MM W/20G X 1.5'' NEEDLE
• Common Device Name: MIXJECT 20MM W/20G X 1.5'' NEEDLE
• 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: 17373215
• Report Number: 3000223297-2023-00011
• Device Sequence Number: 7145816
• Product Code: LHI
• UDI-Device Identifier: 07290108240832
• UDI-Public: 07290108240832
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup
• Report Date (Section B): 05/03/2024

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
• Operator of Device: Other
• Device Model Number: 9070103
• Device Catalogue Number: 9070103
• Device Lot Number: F967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 12/27/2023; 04/07/2024
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/29/2023; 01/24/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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