MAUDE Adverse Event Report: COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Event Description

Bravo calibration free reflux capsule delivery device was found to be damaged when it was removed from the package.This is a one-time use disposable item.It comes in a box of 5, each of the 5 catheters are individually packaged.The tip of one of the catheters was noted to be bent and unable to be used.The other 4 catheters appeared to be undamaged.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 18318006
• MDR Text Key: 330377250
• Report Number: 18318006
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: (01)07290101369714
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-0636
• Device Lot Number: 59834F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1