MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON 10-0 CS160-6 D*; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number U7000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Corrected data (b)(4) - excessive epoxy.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Summary: during the visual inspection of the opened sample, the swage and attachment area of needles were as expected; but, excess of epoxy was noted between the end barrel needle and the suture.The suture was examined along of strand and no defects were noted.Additionally, no marks on the needles were observed.In the visual inspection of unopened samples, no defects were found on the package.The samples were opened, and the swage and attachment area of needles were as expected; however excess of epoxy was noted between the end barrel needle and the suture.The suture was dispensed without problems and examined along of the strand and no defects or damaged were noted.

Event Description

It was reported that the staff reviewed product and noted a yellowish glue-like substance was located at the end of the suture needle.The user found the tear-drop like substance embedded in the needle to suture anchoring point under microscope.The device was not used on a patient.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7910669
• MDR Text Key: 121785243
• Report Number: 2210968-2018-76034
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K946173
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: U7000
• Device Lot Number: JCE945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1