MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 3-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	D7630
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified at the time.Analysis summary: it was received for evaluation an sample of product code d7630, lot pk5182.During the visual inspection of the sample, a portion of the primary packet (folder) was noted in the overwrap seal area, resulting in an open seal and the sterile barrier was compromised.The open seal defect has been correlated to the manufacturing process and a nr was opened.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular surgery on (b)(6) 2020 and suture was used.When opening the package, it was found that the edge of the inner paper package had been caught at the sealed area of the outer package, so the inner package could not be taken out from the outer package.There were no adverse consequences to the patient.

• Brand Name: EB EXC GRN 30IN 3-0 D/A BB
• 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: 11046300
• Report Number: 2210968-2020-10123
• Device Sequence Number: 1193870
• Product Code: GAT
• UDI-Device Identifier: 10705031028111
• UDI-Public: 10705031028111
• 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
• Report Date (Section B): 12/03/2020

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: 08/31/2024
• Device Model Number: D7630
• Device Catalogue Number: D7630
• Device Lot Number: PK5182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1