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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 Fracture (1260)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation: a review of the complaints history, drawings, documentation, instructions for use (ifu), quality control, manufacturing, and specifications of the returned device were conducted during the investigation. Per the user facility form, it was marked that the device was available for evaluation. It was also noted that ¿pictures were sent to the manufacturer. ¿ however, no pictures were received from the complainant and the device was not returned for evaluation. The manufacturer inquired multiple times to gain additional information from the complainant, and no additional information or communication was able to be provided. Thus, the results of the investigation will be based upon the information available from the user facility form. Because the lot number could not be provided, the device history record could not be reviewed. It cannot be determined whether this was the only failure on this device¿s lot. Furthermore, search of our complaint management system revealed only two other complaints detailing a similar failure. Although the proper manufacturing documents are in place, without the work order it cannot be determined whether the reported device was manufactured to specification. Because the device was not returned, a representative device from a previous complaint with a similar failure mode was referenced. Similar to the reported incident from the complainant, the incident discusses how the ventricular catheter broke into two pieces during insertion. Despite an additional supplier investigation on the returned device, it was unable to be determined with certainty what led to the device¿s failure. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. This failure mode has been escalated per internal processes. We will continue to monitor for similar complaints and have notified the proper personnel about this event.
 
Event Description
The customer reported that a 0. 5 cm portion of the tip of a ventriclear drainage catheter fractured during placement of the device and was retained. The patient was operated on four days later, and the fragment was retrieved successfully. No further information is currently available. Additional information has been requested from the customer. It is unknown if the complaint device will be returned; as of the date of this report, no device has yet been received for evaluation. It should be noted this mdr was created from information obtained from user facility form 3500a reference: (b)(4). Further review of the record/event identified that the according to the user facility form, the fracture occurred during removal of the drainage catheter not during placement as previously reported (reported in error). It was also noted this event occurred in (b)(6) of 2017, the exact date is unknown to the manufacturer.
 
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
The customer reported that a 0. 5 cm portion of the tip of a ventriclear drainage catheter fractured during placement of the device and was retained. The patient was operated on four days later, and the fragment was retrieved successfully. No further information is currently available. Additional information has been requested from the customer. It is unknown if the complaint device will be returned; as of the date of this report, no device has yet been received 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
8128294891
MDR Report Key7126857
MDR Text Key256294366
Report Number1820334-2017-04452
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
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 Received03/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/18/2017 Patient Sequence Number: 1
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