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).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > nine unopened samples of product code 1745g, lot llj546 were returned for evaluation.There were no defects found on the packets during the visual inspection.The samples were opened and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects were observed.A functional test was performed and pull force only the sample (# six) did not meet the requirements since, the result was below the minimum individual requirement, the eight other samples met the requirements.According to pull value results , the assignable cause is a needle pull out in the sample six.According to pull value results no performance pull off suture needle was found in eight samples.

• 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: 7476275
• Report Number: 2210968-2018-72493
• Device Sequence Number: 19372199
• 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,Followup
• Report Date (Section B): 04/09/2018

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: 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; 05/24/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/21/2018; 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1