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

Model Number N/A

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the health care provider (hcp) attempted to use the catheter but found that it was defective as there was a hole in the side of it.The hcp was unable to use the device.There was no known impact or consequence to the patient.Additional information has been requested but was not provided the reporter.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control of the returned device was conducted during the investigation.The device was not returned for evaluation, thus, a device failure analysis could not be completed.A lot search for the distribution center indicated that all devices from lot 8094141 were distributed to customers; therefore, no representative device from the same lot could be investigated.Previously completed and similar complaints were reviewed, however, it was unable to be determined with certainty what could have led to the reported failure.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

No new event description information to report at this time.

• Brand Name: VENTRICLEAR DRAINAGE CATHETER SET
• Type of Device: NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7364357
• MDR Text Key: 103298044
• Report Number: 1820334-2018-00425
• Device Sequence Number: 1
• Product Code: NHC
• UDI-Device Identifier: 00827002441309
• UDI-Public: (01)00827002441309(17)190712(10)8094141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 50318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1