PROLENE SUT 30IN(75CM) 6-0 BLU 8709H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PROLENE SUT 30IN(75CM) 6-0 BLU 8709H manufactured by Ethicon Inc..

Event Text Entries

[188523648] (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Additional information was requested and the following was obtained: event date - unknown. Account didn't specify. Please provide specific quantity of devices with product code and lot number involved in this single procedure. Unknown - sending three boxes. Evaluation: unopened samples of product were received. During the visual inspection of unopened samples, no defects were found on the packages. The samples were opened, and the swage and attachment area were noted to be as expected. The sutures were dispensed without problems and examined along of the strand with no defects, damage or suture breakage were noted. A functional test was performed and the tensile strength force was above the minimum requirement. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Per the condition of the samples received, no suture breakage was found and the tested samples met the finished goods requirements.
Patient Sequence No: 1, Text Type: N, H10


[188523649] It was reported that a patient underwent cabg procedure on (b)(6) 2020 and the suture was used. During surgery, the surgeon went to tie the anastomosis when the sutures broke. New sutures were used to complete the case with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02479
MDR Report Key9908106
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-02-01
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-10-18
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-SAN LORENZO PR
Manufacturer Street982 ROAD 183 KM 8.3
Manufacturer CitySAN LORENZO 00754
Manufacturer Country*
Manufacturer Postal Code00754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROLENE SUT 30IN(75CM) 6-0 BLU
Generic NameSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Product CodeGAW
Date Received2020-03-31
Returned To Mfg2020-03-19
Model Number8709H
Catalog Number8709H
Lot NumberPLH703
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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