MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK10-0 30 2XTGW140-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1770

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent to the fda: 02/12/2020.(b)(4).A manufacturing record evaluation was performed for the finished device lot mgr952, and no non-conformance's were identified.Investigation summary: one opened sample of product code w1770, mgr952 was received for analysis.The product code is double armed.During visual inspection of opened sample, the swage and attachment area were noted to be as expected; however, an excessive epoxy was observed between needle and suture resulting in a foreign matter.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition of opened sample, the assignable cause is excessive epoxy resulting in foreign matter.Unopened samples of product code w1770, mgr952 were received for analysis.The product code is double armed.During visual inspection of the unopened samples, no defects were found on the packages.Samples were opened and the swage and attachment area of needles were observed as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or foreign matter were observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition of the samples, no foreign matter non-biological/unknown was found.A photo was returned.Upon visual inspection of the picture, a partially dispensed needle-suture inside a winding former could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the photo, it could not be determined what may have caused the reported incident.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, foreign material was found.It was observed on the between thread and needle with the magnifying glass.There were no adverse patient consequences reported.Upon evaluation of the returned device, excessive epoxy was found.There was no additional information provided.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9701003
• MDR Text Key: 192437569
• Report Number: 2210968-2020-01133
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: W1770
• Device Lot Number: MGR952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1