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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC
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ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Model Number EPM8745
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/13/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.
 
Event or Problem Description
It was reported that a patient underwent a cabg heart procedure on (b)(6) 2020 and suture was used.During the procedure, while suturing the distal portion of the anastomosis, the suture broke at the mid-point.Another like device was used to complete the procedure with no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
PRLNE BLU 4X24IN 7-0 D/A BV175-8 EP
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9814988
Report Number2210968-2020-01913
Device Sequence Number1551646
Product Code GAW
UDI-Device Identifier10705031134836
UDI-Public10705031134836
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K133356
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/18/2020
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 Model NumberEPM8745
Device Catalogue NumberEPM8745
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/18/2020
Initial Report FDA Received Date03/10/2020
Patient Sequence Number1
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