MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL BIC 4X75CM 2/0 V-6 +PLEDG; SUTURES - NON-ABSORBABLE

Catalog Number MEH7714LG

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 an unknown surgery on an unknown date and suture was used.During the procedure, it was found that there had been only green sutures in the package though it should be green sutures and white sutures.There were 2 green needle-sutures in total in the package.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: ETHIBOND EXCEL BIC 4X75CM 2/0 V-6 +PLEDG
• Type of Device: SUTURES - NON-ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8731651
• MDR Text Key: 149108519
• Report Number: 2210968-2019-83252
• Device Sequence Number: 1
• Product Code: GAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: MEH7714LG
• Device Lot Number: ML5589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1