MAUDE Adverse Event Report: ETHICON INC. PROLENE BLUE 1.5M 90CM W/2 NDL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number W8329

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

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

Event Type  malfunction  

Event Description

It was reported that a patient underwent a unknown procedure an an unknown date and suture was used.During the procedure, the needle easily deformed, and the suture was easily broken.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint number: (b)(4).Date sent to the fda: 6/7/2022.(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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/1/2022 h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned sample.Visual analysis of the returned sample revealed that one empty opened labeled winding former and a needle-suture piece of product code w8329 were returned analysis.The product code is double armed.Visual analysis of the returned sample determined that, the swage and attachment area was noted to be as expected.The needle was noted with marks that appear to be by use of surgical instrument at the middle needle and this section was noted bending.In addition, the other section of the suture and the needle were not received.The condition of the sample received indicates improper handling of the device.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The suture piece present body fluids and the end was observed cut possibly from a surgical instrument.The condition of the sample received indicates improper handling of the device.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 BLUE 1.5M 90CM W/2 NDL
• 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: 14627395
• MDR Text Key: 301639829
• Report Number: 2210968-2022-04362
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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: W8329
• Device Lot Number: REBBKR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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