MAUDE Adverse Event Report: ETHICON INC. ETHILON SUT 18IN(100CM) 2-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	W736G
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Investigation summary: visual analysis of the returned sample determined that one bottom tyvek and a labeled winding former with an undispensed needle/suture of product code w736 were received for evaluation.As per visual inspection of the sample received, the tyvek was examined and open seal area was observed, since a portion of the primary packet was caught in the seal area, causing an open seal.The visual inspection concluded that the sterile barrier was compromised.The primary packet in the overwrap seal and open seal defects have been correlated to the manufacturing process.Based on the information currently available, the primary packet in the overwrap seal and open seal were identified during the investigation of the sample received.This product issue will be addressed through quality system.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that before use on the patient on (b)(6) 2021, the packaging condition is not good.Upon evaluation of the returned sample, the tyvek was examined and open seal area was observed,.The visual inspection concluded that the sterile barrier was compromised.No additional information was provided.

• Brand Name: ETHILON SUT 18IN(100CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12862832
• Report Number: 2210968-2021-11953
• Device Sequence Number: 4351630
• Product Code: GAR
• UDI-Device Identifier: 10705031237759
• UDI-Public: 10705031237759
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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 Expiration Date: 05/31/2025
• Device Model Number: W736G
• Device Catalogue Number: W736G
• Device Lot Number: QGMEXR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown