MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 30CM M0.2 10/0 U-20; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number U7003

Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

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 Description

It was reported that a patient underwent a glaucoma procedure on an unknown date in (b)(6) 2019 and suture was used.The suture left a larger hole than normal in the tissue.Upon closer inspection, it was seen that the needle end was not properly closed around the suture and excess glue in the back of the needle.As a complication, there was an increased leakage after the needle stick but the patient was not injured.The procedure was not delayed and was completed successfully.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Additional investigation summary: it was received for analysis an opened folder with a parked needle suture piece of product code u7003.During the visual inspection of the sample, it was observed in the area of stamping and bonding with crack barrel and marks on the needle body.In addition excess of epoxy was noted inside of the needle barrel and also the end of the suture was observe to be cut that appears to be due to the use of a surgical instrument.Marks were observed on the body of the needle.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Due to the sample condition, the assignable cause of excess of epoxy, suggests an improper handling of the sample due to the needle barrel was cracked.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/09/2019.The following information was requested, but unavailable: was there any adverse patient outcome? if yes, please explain was there any medical or surgical intervention performed? update to patient current condition.

• Brand Name: ETHILON BLK 30CM M0.2 10/0 U-20
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9171656
• MDR Text Key: 161785847
• Report Number: 2210968-2019-88506
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: U7003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/08/2019
• Patient Sequence Number: 1