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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GUT PLAIN SUTURE 18"(45CM) 4-0 UND; SUTURE, ABSORBABLE, NATURAL
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ETHICON INC. GUT PLAIN SUTURE 18"(45CM) 4-0 UND; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Catalog Number 1824H
Medical Device Problem Code Detachment Of Device Component (1104)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/09/2018
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
 
Event or Problem Description
It was reported that a patient underwent an unspecified ent procedure on (b)(6) 2018 and suture was used.The needle came off of the suture while pulling it through tissue.Procedure was completed with additional suture from the same box.There were no patient consequences reported.
 
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Brand Name
GUT PLAIN SUTURE 18"(45CM) 4-0 UND
Common Device Name
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
MDR Report Key7231307
Report Number2210968-2018-70570
Device Sequence Number16616903
Product Code GAL
UDI-Device Identifier10705031002654
UDI-Public10705031002654
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/11/2018
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 Expiration Date01/31/2022
Device Catalogue Number1824H
Device Lot NumberLBZ068
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/11/2018
Initial Report FDA Received Date01/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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