MAUDE Adverse Event Report: COOK, INC. UNKNOWN; EZL CATHETER, RETENTION TYPE, BALLOON

Model Number N/A

Device Problem Deflation Problem (1149)

Patient Problem Surgical procedure, additional (2564)

Event Date 04/10/2015

Event Type  Injury  

Event Description

The user facility was unable to deflate the balloon or to remove the catheter the balloon was deflated by puncturing the balloon under ultrasound.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Mfg date: unknown as lot # is unknown.Event evaluation: one foley catheter was returned, but it was not a cook inc.Device.The device appears to be an 8 fr rusch 100% silicone foley catheter per the printed information on the hub.Based on the information available, the complaint did not occur with a cook device.

Event Description

The user facility was unable to deflate the balloon or to remove the catheter.The balloon was deflated by puncturing the balloon under ultrasound.On 29 july 2015, it was confirmed the device was not manufactured by cook inc.

• Brand Name: UNKNOWN
• Type of Device: EZL CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4821447
• MDR Text Key: 5839538
• Report Number: 1820334-2015-00345
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention