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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC OPEN-END URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
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COOK INC OPEN-END URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 020116
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/15/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
It was reported that prior to the procedure, there was a blockage when the thread was passed through the open-end ureteral catheter.It was further noted that the distal catheter was occluded with a small amount of green plastic.There was no patient contact.
 
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Brand Name
OPEN-END URETERAL CATHETER
Common Device Name
GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7409564
Report Number1820334-2018-01052
Device Sequence Number13623042
Product Code GBL
UDI-Device Identifier00827002144309
UDI-Public(01)00827002144309(17)180816(10)6126141
Combination Product (Y/N)N
Initial Reporter CountryNZ
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/09/2018
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 Catalogue Number020116
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2018
Initial Report FDA Received Date04/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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