MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 75CM M0.7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number F1811

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

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: pc (b)(4).Additional information was requested and the following was obtained: how many devices were involved during this single procedure being reported? could you please confirm how many devices presented thread pull- off? could you please confirm how many devices presented suture breakage? could you please confirm how many needles became deformed? how were they deformed? were the needles bent during the procedure? or did any needle broke? please confirm if all the reported issues occurred during the same procedure? were there any patient consequences? procedure name and date? all the devices had the same issues: the threads pulled off, broke and the needles became deformed.Procedure date : (b)(6) 2021.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.Events reported via: (b)(4).

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, on multiple occasions during the operation, the threads pulled off, broke and the needles became deformed.The surgeon changed the suture 4 times and encountered the same problem.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 06/15/2021.H6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device, 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.

• Brand Name: PROLENE BLU 75CM M0.7
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11703690
• MDR Text Key: 262954076
• Report Number: 2210968-2021-03600
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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: F1811
• Device Lot Number: QLBCCL
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1