MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 36IN 2-0 D/A SH 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	PXX86
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
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.H6 component code: g07002 device not returned attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained: please confirm, - how many devices demonstrated the alleged deficiency? -3 eaches - how many devices are available for product return? -3 eaches please not that two eaches were the lot# above, but one was the following lot: tempcd.
Event or Problem Description
It was reported that a patient underwent a cv procedure (b)(6) 2025 and suture was used.During the procedure, the suture pack was defective.The pack was supposed to be preloaded with a pledget and from the front it looks fine but from the back side, it is crooked and coming out almost from the side.Another like device was opened.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b1, b2, h1 - this medwatch report was previously sent in error and is being voided.There has been no report of material separation and the event does not meet the criteria of a us fda reportable event under 21 cfr part 803.

• Brand Name: EB EXC 5GRN/5WHT 36IN 2-0 D/A SH 10PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21230171
• Report Number: 2210968-2025-00915
• Device Sequence Number: 20906103
• Product Code: GAT
• UDI-Device Identifier: 10705031049413
• UDI-Public: (01)10705031049413(17)280430(10)TEMPCD
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: PXX86
• Device Lot Number: TEMPCD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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