MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X36IN 5-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	M8220
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.The returned product determined that it was one sealed overwrap packet that pertained to the product code m8220.During visual inspection of the returned sample, an unknown foreign matter was observed on the straight packet inside the sealed overwrap.However, the integrity of the packet was not compromised.Based on the information currently available, the foreign matter was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.The following information was requested but unavailable: where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?).Please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? are there any photos of the foreign matter available? was the product seal on the foil still intact when the package was opened? will the device be returned for evaluation? if yes please return all relevant packaging material please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).
Event or Problem Description
It was reported that a patient underwent a coronary procedure on (b)(6) 2024 and suture was used.Prior to the procedure, it was immediately found that there had been foreign matter.The package was not opened.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 2X36IN 5-0 D/A C-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19605610
• Report Number: 2210968-2024-06583
• Device Sequence Number: 8085263
• Product Code: GAW
• UDI-Device Identifier: 10705031045613
• UDI-Public: 10705031045613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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: Health Professional
• Device Catalogue Number: M8220
• Device Lot Number: SMBESM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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