MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4) the event is currently under investigation.

Event Description

According to the initial reporter, the user facility has had 5 post operative infections cases from the same urologist.Additional information has been requested but not provided at the time of this report.

Manufacturer Narrative

(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, drawing, and manufacturing instructions of the product was conducted.There is no evidence to suggest that this product was not manufactured to current specifications.The product was not returned.However, the root cause has been identified as related to the patient condition.The patient developed an infection after the catheters had been implanted in the patient during the procedure.The most likely cause for this event would be that the device was contaminated during the insertion procedure or that the patient had an adverse reaction to the device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

According to the initial reporter, the user facility has had (b)(4) post operative infections cases from the same urologist.Additional information has been requested but not provided at the time of this report.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5232887
• MDR Text Key: 31489767
• Report Number: 1820334-2015-00793
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015,11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021305
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2015
• Date Manufacturer Received: 10/29/2015
• 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
• Patient Outcome(s): Life Threatening