MAUDE Adverse Event Report: UNISENSOR USA, INC UNITIP CATHETER FOR HR CATHETER; UNITIP HIGH RESOLUTION CATHETER 12F

Model Number K1232345-L5-121114-

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/01/2014

Event Type  Other  

Event Description

On (b)(6), the doctor at the hosp noticed that the clinician was not disinfecting the anorectal probe after use.When asked about that, she said that she had not been trained to disinfect the probe.However, prior to this time, on (b)(6), the sandhill sales rep had been to the account and performed training on proper operation including cleaning and disinfecting of the probe.On (b)(6) when the sales rep was again at the account on routine business, the doctor said he had discovered that the clinician had not disinfected the probe and five different pts' had studies performed using this probe.Thus, potential injury, due to cross contamination of pts, is possible due to using the contaminated anorectal probe.This report is being submitted as a medical device report in an abundance of caution.Initial notice of the potential for injury.Results of the eval of the pts and the product have not been communicated to sandhill.This is outside of the control of sandhill since we do not have access to this info.Eval (b)(4).(b)(6).

• Brand Name: UNITIP CATHETER FOR HR CATHETER
• Type of Device: UNITIP HIGH RESOLUTION CATHETER 12F
• Manufacturer (Section D): UNISENSOR USA, INC; portsmouth NH
• MDR Report Key: 3761535
• MDR Text Key: 16551546
• Report Number: MW5035710
• Device Sequence Number: 1
• Product Code: FFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: K1232345-L5-121114-
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1