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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
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ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Catalog Number ULT8.5-38-40-P-32S-CLB-RH
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
During the procedure, bile leakage was found at the joint of catheter and lock.The patient did not require any additional procedures due to this occurrence and did not have any adverse effects.A section of the device did not remain inside the patient¿s body.
 
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Brand Name
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Type of Device
GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7010972
MDR Text Key92743622
Report Number1820334-2017-03948
Device Sequence Number1
Product Code GCA
UDI-Device Identifier00827002094970
UDI-Public(01)00827002094970(17)170501(10)5002829
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2017
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
Device Operator Health Professional
Device Catalogue NumberULT8.5-38-40-P-32S-CLB-RH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/07/2017
Initial Date FDA Received11/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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