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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET DYB INTRODUCER, CATHETER

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COOK INC ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2021
Event Type  malfunction  
Event Description
Hold at 2. 28 it was reported that foreign matter was found of the needle of a rosch-uchida transjugular liver access set when the user opened the packaging. No patient contact was made. There was no impact to the patient.
 
Manufacturer Narrative
Customer (person): street: (b)(4). Occupation: unknown. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
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Brand NameROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13256215
MDR Text Key294163601
Report Number1820334-2022-00057
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10827002069296
UDI-Public(01)10827002069296(17)240509(10)13951023
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K171820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberRUPS-100
Device Lot Number13951023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received07/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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