MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8557H
Medical Device Problem Codes	Component Missing (2306); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.Incorrect quantity-extra needle & needle rust.It was found that there was an extra needle with rust on it before using the suture, which was not opened for use.No additional information could be provided.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/23/2026.H6 component code: c22 - photo analysis.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, 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-conformances were identified.Additional information was requested, the following was obtained: did this issue contribute to any patient adverse event? --no.Is it possible that the foreign material fell into packaging upon opening of device? was the suture seals on the foil still intact when the package was opened? where was the hole, puncture, or tear found? (kit carton, pre-filled syringe packaging, or tip packaging) --please refer to the event description, other information requested is unknown.H3 photo analysis: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a single barrier folder labeled 8557h, batch number 101ag3 double-armed.An additional needle loose inside the package.The product code must contain two needles.The incorrect number of needles observed during visual assessment has been correlated with the manufacturing process.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Based on the information currently available, the extra needle was identified during the investigation of the sample received.This product issue will be addressed through ethicon¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: PROLENE
• 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: 24965803
• Report Number: 2210968-2026-04387
• Device Sequence Number: 10428542
• Product Code: GAW
• UDI-Device Identifier: 10705031017061
• UDI-Public: (01)10705031017061(17)290430(10)101AG3
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 8557H
• Device Lot Number: 101AG3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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