MAUDE Adverse Event Report: ETHICON, INC CATGUT CHROM 75CM M3.5; SUTURE, ABSORBABLE, NATURAL

Catalog Number W44801

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.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.

Event Description

It was reported that a patient underwent a c-section on (b)(6) 2018 and suture was used.During the procedure, the suture detached from the needle.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/15/2018.

Manufacturer Narrative

Product complaint # pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An opened foil, a needle/suture of product was returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.Present body fluids and marks on the body needle appears to be by the use of a surgical instrument.The suture was examined for visual inspection and present body fluids along of the strand.However, no defects or needle pull was observed.The sample was tested for needle pull and met the finished goods requirements.Per the condition of the representative sample, no attachment defects or performance-pull off suture needle was found and the tested needle/suture combination met the finished goods requirements.

• Brand Name: CATGUT CHROM 75CM M3.5
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON, INC; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; 312379@b-15/1; m.i.d.c., 1 walu; aurangabad ; IN
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7241254
• MDR Text Key: 99184271
• Report Number: 2210968-2018-70659
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: W44801
• Device Lot Number: VE701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 02/08/2018; 03/06/2018
• Supplement Dates FDA Received: 02/15/2018; 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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