MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 6-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1698G
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	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Additional information was requested, and the following was obtained: - could you kindly verify whether the foreign matter discovered is of a biological nature, such as the presence of blood, insects, hair, or any other biological substance? >no.It was a black matter.- could you please confirm the location of the foreign matter reported in this complaint: inside the sterile barrier or outside of the sterile barrier? >inside the sterile barrier.Attempts are being 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6 component code: g07002 ¿ device not returned related events captured via: 2210968-2024-05198 2210968-2024-05199.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on 23-april-2024 and suture was used.It was found that the suture had foreign matter present.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9 h3 evaluation: the product was returned to for evaluation.One sealed sample that pertain to product code was received for analysis.During visual inspection of the returned sample, a black foreign matter was observed inside the packet.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.

• Brand Name: ETHLN BLK 18IN 6-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19260643
• Report Number: 2210968-2024-05199
• Device Sequence Number: 20503228
• Product Code: GAR
• UDI-Device Identifier: 10705031002180
• UDI-Public: 10705031002180
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 1698G
• Device Lot Number: TLBDRX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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