MAUDE Adverse Event Report: ETHICON INC. INTERCEED* (TC7); BARRIER, ABSORBABLE, ADHESION

Catalog Number	4350
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2018 and the absorbable adhesive barrier was used.The device was found unsealed for the sterile packaging, and no sealing glue.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/11/2019.The following additional information was received: during the surgery, 1 unit was found unsealed.Two unsealed units were found after surgery when checked their stock, which are from the same lot.Malfunctions reported via manufacturer report # 2210968-2018-77919, 2210968-2018-77922, 2210968-2018-77923.
Additional Manufacturer Narrative
Date sent to the fda: 03/04/2019.Additional summary: one (1) opened sample of product was returned for analysis.Sample was numbered to evaluate the variety of failure modes as different pouch conditions were found.Sample # 3 was found closed on the chevron side but was unsealed on the non-chevron side of the sterile packaging.It can be concluded that this was one of the units found in the inventory after the subject unit was found as it has an open seal and it was closed in the chevron side.

• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8183326
• Report Number: 2210968-2018-77923
• Device Sequence Number: 11127746
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: 10705031005396
• Combination Product (Y/N): N
• PMA/510(K) Number: P880047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2018

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: 11/30/2022
• Device Catalogue Number: 4350
• Device Lot Number: MCB3232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/13/2019; 02/24/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/11/2019; 03/04/2019
• Patient Sequence Number: 1