MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 6-0 D/A G-1 PRM; SUTURE, ABSORBABLE, NATURAL

Model Number 770G

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The following information was obtained: the lot # is rdmlej.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.

Event Description

It was reported that a patient underwent an unknown procedure in 2021 and suture was used.Before use on the patient, it was reported that a hair was found inside the packaging.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/4/2021.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 number rdmlej and no non-conformances related to the reported complaint condition were identified.Additional information: d4, h4, h6.Additional h3 investigation summary: the product was not returned for evaluation.Visual inspection was conducted on the pictures received.Visual analysis was performed to one picture received and it was observed one sealed overwrap packet with a foreign matter that appears to be a hair into the packet.The product code is 770.A foreign matter was observed during the visual assessment and has been correlated to the manufacturing process.Based on the information currently available, the foreign matter was identified during the investigation of the picture received.

• Brand Name: GUT PL UD 18IN 6-0 D/A G-1 PRM
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12398537
• MDR Text Key: 269302028
• Report Number: 2210968-2021-07876
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031010475
• UDI-Public: 10705031010475
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 770G
• Device Catalogue Number: 770G
• Device Lot Number: RDMLEJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1