MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Occupation: nurse manager.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that two cook picc devices ruptured in unknown patients.Additional information regarding the event and patient outcome 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.Crouse health hospital, inc (united states) contacted cook stating that they had another picc catheter where the catheter burst.Reviews of documentation including the quality control and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.The customer was not able to provide rpn numbers, gpn numbers, or lot numbers to aid in the investigation.It was reported the device was a dual lumen rifampin picc catheter.It was possible to narrow the investigation down to three possible rpns the catheter could have come from: upicds-5.0-ct-abrm-1111, upicds-5.0-ct-nt-abrm-1111, and upicds-5.0-ct-40nt-abrm-1111.A generalized device master record was able to be reviewed using these three rpns and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The three possible rpns are supplied with the same instructions for use (ifu) t_upicabrmtt_rev1.Under how supplied it states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the available information, no device return, and the results of the investigation, a possible root cause for this event could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

• Brand Name: UNKNOWN
• 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: 12144439
• MDR Text Key: 264319725
• Report Number: 1820334-2021-01733
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1