MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 3-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X588H
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional information was requested and the following was obtained: lot # qbmmba.The following information was requested, but unavailable: please provide procedure name and date.No further information is available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was to be used.During the procedure, a hair was noted.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/27/2021.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 qbmmba and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary : one sealed overwrap packet product code x588 was returned to ethicon inc for analysis.Upon initial inspection to the sample no foreign matter or defects were observed on the sample received.As per visual analysis of the sample received a foreign matter (hair) caught in the a section of the seal area was observed.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 sample received.

• Brand Name: EB EXC GRN 36IN 3-0 D/A BB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12542519
• Report Number: 2210968-2021-08920
• Device Sequence Number: 1205160
• Product Code: GAT
• UDI-Device Identifier: 10705031057692
• UDI-Public: 10705031057692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: X588H
• Device Catalogue Number: X588H
• Device Lot Number: QBMMBA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1