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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC VENTRICLEAR DRAINAGE CATHETER SET NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)

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COOK INC VENTRICLEAR DRAINAGE CATHETER SET NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS) Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use, quality control, trends and visual examination of the device was conducted during the investigation. A device failure analysis was completed by the supplier. Two open and used catheters were returned. Catheter 1: the catheter was returned in two pieces of lengths 20 cm and 12 cm respectively. Both edges at tear site appeared to be jagged. The returned segments were patent and passed leak testing when tested individually. Proteinaceous debris was observed within the interior and exterior of the catheter. Catheter 2: approximately 21cm of the catheter was returned. Both edges appeared to be jagged. The returned segment was patent and passed leak testing. Proteinaceous debris was observed within the interior and exterior of the catheter. A document based investigation evaluation was also performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the information provided, evaluation of the returned device by the supplier and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Measures have been initiated to address this failure mode. Per the quality engineering risk assessment no further action is required.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
A representative of a spinal and orthopedic device manufacturer reported that a physician stated the ventriclear drainage catheter broke off during an unspecified procedure during insertion. Additional information was requested regarding retrieval of the device and patient outcome; however, at this time no further information is available from the initial reporter. The contact information for the reporting physician, including user facility information is not available. A statement that this event occurred multiple times cannot be validated. There is no further information available and the device is not available for evaluation.
 
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Brand NameVENTRICLEAR DRAINAGE CATHETER SET
Type of DeviceNHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6559714
MDR Text Key196703237
Report Number1820334-2017-01018
Device Sequence Number1
Product Code NHC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number50318
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2017 Patient Sequence Number: 1
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