MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 7-0 D/A CS175-8; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1745G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that the patient underwent an eye procedure on (b)(6) 2018 and suture was used.The needle separated from the swage while passing through tissue with little tension.A like device of alternate product code was used to complete the procedure.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).An unopened representative sample was returned for analysis.During the visual inspection of sample, no defects were found on the package.The sample was opened and the swage and attachment area needles were as expected.The suture was dispensed without problems and examined along of the strand and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.Per the conditions of the sample received, no attachment defects were found and the tested sample met the finished goods requirements.

• Brand Name: GUT CHR UD 18IN 7-0 D/A CS175-8
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7476321
• Report Number: 2210968-2018-72495
• Device Sequence Number: 1124929
• Product Code: GAL
• UDI-Device Identifier: 10705031002340
• UDI-Public: 10705031002340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 1745G
• Device Lot Number: LLJ546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1