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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED ROSCH-UCHIDA INTRODUCER, CATHETER

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COOK INCORPORATED ROSCH-UCHIDA INTRODUCER, CATHETER Back to Search Results
Model Number G06929
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
Upon inspection during preparation, it was noted that the needle of the access set appears to have a rust spot on the proximal tip. The access set was removed, and a new set was opened. There was no harm to the patient.
 
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Brand NameROSCH-UCHIDA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key13175175
MDR Text Key283413546
Report Number13175175
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG06929
Device Catalogue NumberRUPS-100
Device Lot Number14189787
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2021
Event Location Hospital
Date Report to Manufacturer01/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
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