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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 5-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE
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ETHICON INC. PDSII VIO 27IN 5-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Model Number Z303H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/23/2020
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
 
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the suture thread broke.No adverse patient consequences reported.No additional information was provided.
 
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Brand Name
PDSII VIO 27IN 5-0 S/A RB-1
Common Device Name
SUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key11628893
Report Number2210968-2021-03052
Device Sequence Number19829571
Product Code NEW
UDI-Device Identifier10705031060357
UDI-Public10705031060357
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
N18331
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/16/2021
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 Date11/30/2022
Device Model NumberZ303H
Device Catalogue NumberZ303H
Device Lot NumberLPZ593
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/16/2021
Initial Report FDA Received Date04/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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