MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 5IN 10-0 S/A BV75-3; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W2790
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a pterygium excision surgery on (b)(6) 2025 and suture was used.It was reported from the analysis of the returned product that wrong and/or mixed packaging component was observed.Incorrect quantity-missing packages.It was reported that there was one package of product less than expected in the box when just opened.There should be twelve packages of products in the box, but actually there were only eleven packages of products.Changed another one to complete the surgery.There is no report on patient's injury.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 2/5/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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-conformance's were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One opened box belonging to product code w2790 was received for analysis.Upon visual inspection of the received box, it was noted that it contained eleven overwrap packets instead of the required twelve.However, it could not be determined whether only eleven samples were originally placed inside the box.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Although no conclusion could be reached regarding the cause of the reported event, as part of ethicon's quality process, all devices are manufactured, inspected, and released to approved specifications.Further monitoring of complaint information will be performed for potential safety signals through complaint trending as part of post-market surveillance.

• Brand Name: PRLNE BLU 5IN 10-0 S/A BV75-3
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24267548
• Report Number: 2210968-2026-01322
• Device Sequence Number: 10669329
• Product Code: GAW
• UDI-Device Identifier: 10705031126077
• UDI-Public: (01)10705031126077(17)290930(10)104896
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: W2790
• Device Lot Number: 104896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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