MAUDE Adverse Event Report: BECTON DICKINSON/ C.R. BARD, INC. PUREWICK; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Model Number PWF030

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

Event Type  Other  

Event Description

I am an 87 year old retired rn.Earlier this year i was hospitalized to have my gallbladder out.I ended up spending 2 weeks in the hospital.My room was marked behind my bed and on the door that i have latex allergy.I was bedridden, not able to get up to go urinate in the bathroom, so staff elected to use a purewick device to suction away my urine to a container by the wall.Just before the first purewick was fitted to me my visitor noticed that its package said "contains dry natural rubber," and he asked staff to check to see if that meant that it included latex.They initially thought that it would be ok.My visitor had actually encountered purewicks several years before and he persisted with the question and eventually staff figured out that indeed did contain latex and that there was a non-latex version available from their supply room.After a few hours they obtained a small quantity of the non-latex version and used it with no further problems except that we needed to continue each day to make sure that the night shift didn't replace a containing one since they look identical (same color) and have very similar part numbers.

• Brand Name: PUREWICK
• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): BECTON DICKINSON/ C.R. BARD, INC.
• MDR Report Key: 17603965
• MDR Text Key: 321926681
• Report Number: MW5144861
• 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
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PWF030
• Patient Sequence Number: 1
• Patient Age: 87 YR