MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD MIXJECT 13MM FTH RIBS 30G

Model Number 9070115

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

The customer, (b)(6), contacted west pharma services, il ltd (west il) on (b)(6) 2023 to report that during in-process inspection and prior to use of the mixject 13mm fth ribs 30g, lot f575, five units were discovered to be missing the tyvek sealing foil.

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 which showed the missing tyvek sealing foil.Upon completion of the west il investigation and if additional information is provided from the customer, a follow up report will be submitted.

Manufacturer Narrative

West pharma services il (west il) investigated a complaint received by bayer ag, regarding five units of the mixject reported to be missing the tyvek sealing foil on each unit.All five samples were returned to west il for evaluation on (b)(6) 2023 and were confirmed missing the tyvek seal.Additionally, there was no observed sealing marks on the blister of all five returned units.Retained samples of lot#f575 were visually inspected and no issues were noticed; all the (b)(4) products were sealed.According to batch records review on lot number f575 no issues were noticed.However, it is likely that during the manufacturing process, the five unsealed and rejected products, may have been unintentionally manually placed into a sealing bag by the sub-contractor as finished product.According to the sub-contractor's investigation report, training for relevant employees was performed to raise awareness on their procedure to prevent future occurrence of this event.The sub-contractor has since updated their procedure to reflect collection of rejected products in a designated bag and area.Additionally, a supervisor is overseeing the production area for better quality control.Therefore, insufficient procedure for collecting rejected products during production, is the most probable root cause for this reported issue.

• Brand Name: MIXJECT 13MM FTH RIBS 30G
• Type of Device: MIXJECT 13MM FTH RIBS 30G
• 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: 17373410
• MDR Text Key: 319881812
• Report Number: 3000223297-2023-00012
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108241044
• UDI-Public: 07290108241044
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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: Other
• Device Model Number: 9070115
• Device Catalogue Number: 970136
• Device Lot Number: F575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2022
• 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