MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 18"(45CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP683H
Medical Device Problem Code	Extrusion (2934)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Reaction (2414); Not Applicable (3189); No Code Available (3191)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch lh8crws0, manufacturing date: 07-01-2017, expiration date: 06-30-2020; batch lc8bgzs0, manufacturing date: 03-01-2017, expiration date: 02-29-2020; batch ld8ctcs0, manufacturing date: 04-01-2017, expiration date: 03-31-2020; batch kj8chhs0, manufacturing date: 08-01-2016, expiration date: 07-31-2019; batch kk8btms0, manufacturing date: 09-01-2016, expiration date: 08-31-2019.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Attempts are being 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 the patient underwent caesarean section on an unknown date and suture was used.Following the procedure, the patient experienced pain and irritation in the suture area.Local redness of the seam was noted, without pus.In some places there were areas of compaction with bubbles, after opening which small granules were separated with piece of defragmented product.The remaining thread was removed from different ends of the seam.The wound was cleaned and suture was used on the skin.No additional information was provided.
Additional Manufacturer Narrative
The actual device was received for evaluation.During the visual inspection of sample, the ends suture pieces were observed cut appears to be by use of a surgical instrument and body fluids were found on the strand pieces.The product code vcp683 contains an absorbable suture and as the sample was received open, the time of exposure that has the suture in the environment could not be determined and no additional test could be performed.Representative samples were examined for visual defects.The packets were opened and during the visual inspection, the swage and attachment area were as expected, the suture strand was correctly placed on the tray and dispensed without problems.No defects or damaged were observed along of suture.According to the sample condition the assignable cause of the event cannot be determined since, no defects were observed on the packet or the suture.

• Brand Name: VICRYL PLUS SUTURE 18"(45CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7439784
• Report Number: 2210968-2018-72165
• Device Sequence Number: 19084479
• Product Code: GAM
• UDI-Device Identifier: 10705031054769
• UDI-Public: 10705031054769
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K032420
• 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
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VCP683H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention