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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

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COOK INC 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 Problems Hub (469); Break (1069); Detachment Of Device Component (1104); Crack (1135); Catheter (3038)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2015
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

The complainant reported that a dressing was being placed on the catheter after the biliary drain placement procedure was over. The catheter and hub broke off about 1 cm (centimeter) down the catheter from the hub. The hub "cracked completely off" when the nurse was putting on the statlock. The doctor exchanged with another catheter and the patient was able to leave the room without issue. It was also reported that the catheter material appeared to be "weak and broke" and that it seemed that "the biliary tubes [were] cracking off and the multipurpose [were ] falling off. " there were no reports of any section of the device remaining inside the patient's body or any adverse effects on the patient as a result of this product problem.

 
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Brand NameULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Type of DeviceGCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7014553
MDR Text Key92747120
Report Number1820334-2017-03858
Device Sequence Number1
Product Code GCA
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 11/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/17/2015
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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