MAUDE Adverse Event Report: COVIDIEN FOLY CATH 100 SLCON 3CC 10FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number 8887603101

Device Problem Deflation Problem (1149)

Patient Problems Pain (1994); Blood Loss (2597)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed, and approved by quality, prior to release of product.

Event Description

The customer reported that when the balloon was inserted and inflated, the patient experienced intense pain after half an hour and slight bleeding in the penis.When the catheter was removed, it was impossible to deflate the balloon.After several attempts, the balloon was removed, but did not deflate evenly with difficulty in deflating the balloon to remove the injected saline.Consequences to the patient included bleeding, pain, and transfer to necker emergency room.

• Brand Name: FOLY CATH 100 SLCON 3CC 10FR
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10878480
• MDR Text Key: 217713776
• Report Number: 9611018-2020-00465
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 10884521016620
• UDI-Public: 10884521016620
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8887603101
• Device Catalogue Number: 8887603101
• Device Lot Number: 20E027FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1