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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHILON* BLK10-0 30 2XTGW140-6 SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
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.

 
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Type of DeviceSUTURE, 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 Key9701003
MDR Text Key192437569
Report Number2210968-2020-01133
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberW1770
Device LOT NumberMGR952
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/06/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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