MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 36"(90CM) 3-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X558H
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 or Problem Description
It was reported that a customer opened a box of suture on an unknown date and found the suture packet seemed to be contaminated.It was stained yellow on one end, and the yellow had seeped into the packet and was also staining the plastic suture holder.The yellowed packet was interspersed between normal packets within the box.It was reported that the packet smelled funny.The box looked normal, no evidence of staining, and the outer clear plastic seal was not compromised.There was no patient involvement.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 1/112019.Additional evaluation summary: the sample was not returned for evaluation.Only pictures of the sample were received for analysis.Upon visual inspection of the picture, overwraps and winding former with yellow stains could be observed.However, no conclusion could be reached as the sample was not returned for analysis.

• Brand Name: ETHIBOND EXCEL SUTURE 36"(90CM) 3-0 GRN
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8038568
• Report Number: 2210968-2018-76939
• Device Sequence Number: 1465327
• Product Code: GAT
• UDI-Device Identifier: 10705031057579
• UDI-Public: 10705031057579
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 02/28/2023
• Device Catalogue Number: X558H
• Device Lot Number: MCZ959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1