MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 1 S/A CTX; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X865H
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number jmh693, and no non-conformance's were identified.Investigation summary: one labeled winding former with a needle-suture combination of product code x865, lot jmh693 was received for analysis.During visual inspection of the sample, a hair stuck with tape on the paper lid and winding former was observed.In addition the overwrap package was not returned for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the sample condition, it could not be determined what may have caused the reported incident.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.When the suture packet was opened, there was a hair inside with the suture.The device will be returned.There were no adverse patient consequences reported.

• Brand Name: EB EXC GRN 30IN 1 S/A CTX
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9198750
• Report Number: 2210968-2019-88738
• Device Sequence Number: 447400
• Product Code: GAT
• UDI-Device Identifier: 10705031058125
• UDI-Public: 10705031058125
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 10/31/2020
• Device Catalogue Number: X865H
• Device Lot Number: JMH693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1