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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 4-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. VCL CT BRD UD 8X18IN 4-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Model Number J714D
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an unknown procedure on an unknown date; and a suture was used.During the procedure, the needle broke and was not used in the patient.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
VCL CT BRD UD 8X18IN 4-0 S/A RB-1 CR
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10238907
Report Number2210968-2020-05088
Device Sequence Number2624637
Product Code GAM
UDI-Device Identifier10705031042483
UDI-Public10705031042483
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K022269
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) 06/25/2020
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 NumberJ714D
Device Catalogue NumberJ714D
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/25/2020
Initial Report FDA Received Date07/07/2020
Patient Sequence Number1
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