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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 D/A V-5 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 D/A V-5 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Catalog Number SXX50
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Note: events reported via mw # 2210968-2019-91364, 2210968-2019-91365.
 
Event or Problem Description
It was reported that the patient underwent an aortic valve replacement procedure on an unknown date and suture was used.The suture pulled off the needle while drawing normally during the surgery of the aortic valve replacement.Changed to another device to continue the surgery.There were no adverse patient consequences reported.No additional information could be provided.
 
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Brand Name
EB EXC 4GRN/4WHT 30IN 2-0 D/A V-5 8PLGT
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9524677
Report Number2210968-2019-91365
Device Sequence Number16818180
Product Code GAT
UDI-Device Identifier10705031050693
UDI-Public10705031050693
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberSXX50
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/06/2019
Initial Report FDA Received Date12/27/2019
Patient Sequence Number1
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