MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A410

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 07/06/2018.(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Additional information was requested and the following was obtained: no further information.What tissue layer was the stratafix symmetric suture used on? what was the condition of the tissue the suture was used on? were any cultures taken of the wound? and results? what are the patient past medical history? what was the indication for the second procedure 7 days post op? can you describe the appearance of the suture during second procedure? what is the surgeon opinion as to relationship of suture to the patient wound discharge? what is status of suture for evaluation?.

Event Description

It was reported that the patient underwent a cardiovascular cardiovascular/ congenital heart procedure on (b)(6) 2018 and the suture was used.During procedure, there was no anomaly observed.On (b)(6) 2018, the patient returned to hospital due to pain.The patient experienced wound discharge and revision surgery was performed.Stitches were removed and sutured with another one.It was also reported that there was no leukocyte on used sample.Now the patient's condition is stable.No additional information is available.

Manufacturer Narrative

(b)(4).An unopened sample of product code sxpp1a410, lot lgm622 was returned for analysis.The representative sample was examined for visual defects appearance, color packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, and damage (torn, punctured).The packet was opened and during the visual inspection, the suture was correctly placed on the winding former and the suture was dispensed without problems and examined along of the strand and no defects or damaged were observed, the suture not presented defects.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative sample, no defects were observed on the packets or the suture.

• Brand Name: SFX SYM PDS+ VIO 18IN 3-0 S/A SH
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7668370
• MDR Text Key: 113396772
• Report Number: 2210968-2018-74165
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219311
• UDI-Public: 10705031219311
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: SXPP1A410
• Device Lot Number: LGM622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/06/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR