MAUDE Adverse Event Report: BARD MEDICAL / BARD SDN, BHD PUREWICK DRYDOCK VACUUM STATION; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Model Number DD15

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Event Description

My mom has als and uses this product to relieve herself of bodily fluids.She has had this product for less than 4 months and the unit has stopped working.This unit has a limited warranty of 3 years.This can leave her in a state of having urinary infections.I have consulted with mfr and have been informed that we would need to have the unit sent in for inspection, which would take up to 90 days.They will replace the unit if found at fault.I have talked to their distributor and have been informed that they received a lot of these complaints concerning malfunction of unit and are trying to correct process of replacement.I am a biomed tech and the process in the hospital where i worked was to have a replacement sent out and the faulty unit would be sent to the mfr for evaluation.I feel that this company is taken advantage of the home health community.

• Brand Name: PUREWICK DRYDOCK VACUUM STATION
• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): BARD MEDICAL / BARD SDN, BHD
• MDR Report Key: 7757505
• MDR Text Key: 116548792
• Report Number: MW5078909
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DD15
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 91