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

Catalog Number 1745G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2018

Event Type  malfunction  

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 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.

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
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7476255
• MDR Text Key: 107074323
• Report Number: 2210968-2018-72491
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031002340
• UDI-Public: 10705031002340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1