MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 36"(90CM) 1 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP959H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Foreign Body Reaction (1868); Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: please clarify the patient¿s wound opened; did the patient¿s wound dehisce? yes were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no.Was any surgical intervention provided for the reported event? no.What medical intervention was performed? results? antibiotic treatment and resuture of the wound.Condition is back to normal.Product code and lot #: vcp959h, lot mm2915.What is physician¿s opinion as to the etiology of or contributing factors to this event? they still try to understand the cause.What is the patient current status? patient is in good condition.
Event or Problem Description
It was reported that a patient underwent a cardiac surgery on an unknown date and suture was used.It was reported that the patient got infected with an opening of the sternum section.Per custom routine, the sternum was closed in two stages: the subcutaneous layer was sewn with one suture thread and the skin was closed with skin stapler.After the surgery, the patient returned when the incision was reddened and it was observed that the threads were emitted from the incision.The patient had to undergo several treatments until the infection passed.The patient had antibiotic treatment and resuture of the wound.Today the condition of the patient is well and back to normal.The surgeon couldn¿t point the cause of the infection: whether the infection and opening of the incision are the result of a problem with the suture or because of an unknown cause.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).An opened box with unopened samples of product code vcp959, lot # mm2915 were returned for analysis.Representative samples were examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packets were opened and during the visual inspection the needle/suture was correctly placed on the winding former.The sutures were dispensed without problems and examined along of the strand and no defects, damaged on the suture were observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to samples condition, no defects or damage were observed.

• Brand Name: VICRYL PLUS SUTURE 36"(90CM) 1 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: 8595306
• Report Number: 2210968-2019-81213
• Device Sequence Number: 11307855
• Product Code: GAM
• UDI-Device Identifier: 10705031056237
• UDI-Public: 10705031056237
• Combination Product (Y/N): N
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2019

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: No Information
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: VCP959H
• Device Lot Number: MM2915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/14/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention