MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 60CM M0.5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number 8335H

Device Problems Break (1069); Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2022 and suture was used.During the procedure, the thread needle joint is coming apart, the thread breaks, and the needle is bent.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint number: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: 60,70, and 80 viciblack ethicon prolene sutures, were broken off several times from the needle connection and from the middle part in the same operation on (b)(6) 2022.In the meantime, the needle was bended during anastomosis.Additional information has been requested: please confirm how many devices from prolene 8-0 presented the alleged issues (pull-off/suture breakage/bending needle) during suturing on this one patient during this single surgical procedure? * please provide lot number(s) for product code 8307h & 8335h.Please confirm how many devices from product code 8307h presented the alleged issues (pull-off/suture breakage/bending needle) during suturing on this one patient during this single surgical procedure? please confirm how many devices from product code 8335h presented the alleged issues (pull-off/suture breakage/bending needle) during suturing on this one patient during this single surgical procedure? the facility has shared wrong information on 8/0 prolene.Bo problem was seen on8/0 suture lot information: 8307h lot : pch266.8335h lot : pmr713.Both products were used on the same patient in distal coroner artery anastomosis.In total, 5 times the issue was seen in the surgery by both codes 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.Related to: 2210968-2022-03467, 2210968-2022-03468, 2210968-2022-03469, and 2210968-2022-04077.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/27/2022 h6 component code: g07002 no device return a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Related to: 2210968-2022-03467, 2210968-2022-03468, 2210968-2022-03469, 2210968-2022-04077.

• Brand Name: PROLENE BLU 60CM M0.5
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14503494
• MDR Text Key: 294423008
• Report Number: 2210968-2022-04079
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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 Catalogue Number: 8335H
• Device Lot Number: PMR713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/04/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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