MAUDE Adverse Event Report: ETHICON INC. ETHILON BLU 2/0 75CM DBLE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number EH7625E

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 12/19/2017.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a sigmoidectomy procedure on (b)(6) 2017 and suture was used.During the placement of the suture line the suture detached form the needle.There were no adverse patient consequences.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Unopened samples of product were returned for analysis.During the visual inspection of unopened samples, no defects were found on the package.The samples were opened and the swage and attachment area of the needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects were observed.The samples were tested for needle pull and met the finished goods requirements.Per the conditions of the unopened samples received, no attachment defects were found and the tested samples met the finished goods requirements.The actual device was returned for evaluation.The barrel hole was examined and remnant suture was noted.The suture end is severely cut (damaged), resulting in a clip off defect.In the inspection of the needle/suture combination, the swage and attachment area were as expected.According to the sample conditions it was suggest a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: ETHILON BLU 2/0 75CM DBLE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7132387
• MDR Text Key: 95409375
• Report Number: 2210968-2017-71864
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: EH7625E
• Device Lot Number: JC5GLDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1