MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 27IN 2-0 S/A CT-3; SUTURE, ABSORBABLE, NATURAL

Catalog Number	N863H
Medical Device Problem Code	Component Incompatible (1108)
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
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient an unknown procedure on an unknown date and suture was used.Prior to use on the patient, it was noted there were two different needle types on packs inside the same box.No patient involvement was reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: two unopened samples were received for evaluation.During the visual inspection of the two samples, the needle sales type printing on foil packet belong to fn2.The finish drawing was reviewed into the system and the graphic information was confirmed that is correct, the needle sales type belongs to fn2 and the product printed with lot number hj6516 was manufactured on 08/18/2014 revision 11.In addition, the revision number 12 was reviewed into the system and the needle sales type was updated to ct-3 and the graphic was updated with these changes.In addition, the needle characteristic for ct3 and fn2 are the same and both are included in the product description.According to samples and manufacturing date, the printing information on the foils related to needle sales type are correct.A manufacturing record evaluation was performed for the finished device hj6516 batch number, and no non-conformances were identified.

• Brand Name: GUT PL UD 27IN 2-0 S/A CT-3
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8623407
• Report Number: 2210968-2019-81506
• Device Sequence Number: 1968712
• Product Code: GAL
• UDI-Device Identifier: 10705031047396
• UDI-Public: 10705031047396
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/24/2019

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: 07/31/2019
• Device Catalogue Number: N863H
• Device Lot Number: HJ6516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/10/2019
• Patient Sequence Number: 1