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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 13CM M0.4::USP8/0 SGLE ARMED BV130-5 SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHILON BLK 13CM M0.4::USP8/0 SGLE ARMED BV130-5 SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number 2808V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2019
Event Type  Malfunction  
Manufacturer Narrative

A manufacturing record evaluation was performed for the finished device lot number mkz135, and no non-conformances were identified. Investigation summary: it was reported that the device had a product mix / incorrect component issue. An opened sample product code 2808, lot mkz135 was returned for analysis. During the visual inspection of the opened sample, the foam park had 9-0 printed and for product code 2808 should be 8-0 printed. Due to mismatch at the foam park a characterization of the suture was performed and meet the requirements for an ethilon suture diameter 8-0. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. According to the sample condition, the assignable cause of the mix foam park is due to manufacturing defect.

 
Event Description

It was reported that a patient underwent a hand procedure on (b)(6) 2019 and suture was used. The suture was found inside the winder to have been 9-0 threads instead of the 8-0 threads. There were no adverse patient consequences reported.

 
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Brand NameETHILON BLK 13CM M0.4::USP8/0 SGLE ARMED BV130-5
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-JUAREZ
avenida de las torres 7125
col salvacar
ciudad juarez 32604
MX 32604
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8957340
MDR Text Key156343072
Report Number2210968-2019-86499
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeGM
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 08/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number2808V
Device LOT NumberMKZ135
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/10/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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