MAUDE Adverse Event Report: COOK INC

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: nurse manager.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 an unknown cook picc device ruptured.The device burst while the patient was at home, prompting the patient to go to the hospital.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6) hospital, inc.In the united states contacted cook stating that they had another picc catheter rupture.The patient was at home with the picc catheter and came into the hospital at which time it was discovered.Attempts were made to obtain the product rpn, lot number, date of event, and patient outcome but the customer has not responded.A review of the instructions for use (ifu) and quality control procedures were conducted during the investigation.The device was not returned for evaluation.No photographs were provided to aid in the evaluation of the device.However, a document based investigation evaluation was performed.The device master record was reviewed and this product is 100% inspected for nonconformances during the manufacturing process.The customer did not provide a lot number.A sales report was performed to ascertain a lot number and real part number.There were too many lot numbers to determine the lot number.There were three possible real part numbers (upicds-4.0-ct-40nt-abrm-1111/upicds-4.0-ct-nt-abrm-1111/upicds-5.0-ct-40nt-abrm-1111), so the device master record review reflects these devices.This product is supplied with an instructions for use (ifu) pamphlet, t_upicabrmtt_rev1.In the power injection procedure section, it states: 1.) use only lumens marked ¿ct¿ for power injection of contrast media.Warning: use of lumens not marked ¿ct¿ for power injection may result in catheter failure.5.) ensure adequate blood return and flush catheter vigorously with the entire 10ml of sterile normal saline to ensure lumen patency.Warning: failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.In the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the lack of information it cannot be determined if the product was manufactured out of specification, or if there is non-conforming material in house or in the field.Based on the limited information provided, the complaint device not being returned, and the results of the investigation, a definitive cause could not be established.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12134394
• MDR Text Key: 262896797
• Report Number: 1820334-2021-01710
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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