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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHILON BLK 30CM M0.2 10/0 U-20 SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
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 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. 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. 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.

 
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.

 
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Brand NameETHILON BLK 30CM M0.2 10/0 U-20
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.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9261989
MDR Text Key177354882
Report Number2210968-2019-89323
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeSW
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 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberU7003
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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