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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHILON NYLON 10-0 CS160-6 D* SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
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.

 
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Type of DeviceSUTURE, 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 Key7910669
MDR Text Key121785243
Report Number2210968-2018-76034
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeHK
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,Followup
Report Date 08/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device Catalogue NumberU7000
Device LOT NumberJCE945
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/19/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/04/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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