MAUDE Adverse Event Report: ETHICON INC. SURGICAL GUT SUTURE - CHROMIC; SUTURE, ABSORBABLE, NATURAL

Catalog Number 1797G

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: was the product code and lot number on the package verified before opening - yes according to the customer.Did the package containing black and braided suture pulled from the box labeled 1797g lot khj003 - yes according to the customer.Are different suture types stored in the same location - i don't know.Opened sample received: the suture was examined along of the strand and was match with the description of the product code (virtual monofilament and blue color) and no damage was found along of the strand.No black sutures or braided structures were observed on the sample received for evaluation.The exposition time in the environment cannot be determined; however when the suture no longer has contact with the alcohol that is inside the package the color may become blue but darker.According to the sample condition the suture it was observed blue color and monofilament structure this characteristic belong to the product code 1797g.

Event Description

It was reported that the patient underwent an eye surgical procedure on (b)(6) 2017 and the suture was used.During the procedure, when a doctor opened the packet of suture and removed the suture from the packet, it was noticed the suture looked black and braided, as opposed to the expected blue and unbraided with this type of the suture.It was also reported that the suture was not exposed to any type of reprocessing or room decontamination process by hydrogen peroxide vaporization at hospital and hydrogen peroxide vapor in the operating room or any area where the suture was stored.Another like suture was opened and used to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

• Brand Name: SURGICAL GUT SUTURE - CHROMIC
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6323377
• MDR Text Key: 67253831
• Report Number: 2210968-2017-30707
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1797G
• Device Lot Number: KCJ816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1