MAUDE Adverse Event Report: ETHICON INC. EB EXC 1GRN/1WHT/1LT GRN 30IN 2 S/A CP-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	D6090
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) a manufacturing record evaluation was performed for the finished device pam183 batch number, and no non-conformances were identified.Device evaluation summary: an opened sample of product code d6090, lot # pam183 was received for analysis.During the visual inspection of the opened sample, no foreign matter or hair could be observed.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the sample condition no packaging foreign matter biological was noted.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2019 and suture was used.When the sterile packaging was opened and it looked like there was a hair on the needle.It is unknown how the case was completed.There were no patient consequences reported.

• Brand Name: EB EXC 1GRN/1WHT/1LT GRN 30IN 2 S/A CP-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9281299
• Report Number: 2210968-2019-89547
• Device Sequence Number: 19516403
• Product Code: GAT
• UDI-Device Identifier: 10705031026049
• UDI-Public: 10705031026049
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 12/31/2023
• Device Catalogue Number: D6090
• Device Lot Number: PAM183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1