MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM

Catalog Number PW100

Device Problems Biocompatibility (2886); Misassembly by Users (3133); Device Handling Problem (3265)

Patient Problem Urinary Tract Infection (2120)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the purewick urine collection system might be cutting off at night.No proof except for the patient waking up wet.Per followup via liberator by phone on 18feb2021, patients stated that the new unit had no suction.Representative did troubleshooting over the phone and the unit had suction.The unit leaked out on the bottom and patient ended up with a urinary tract infection.The old dd15 was working fine and the new unit was purchased for back up.Advised that liberator representative would replace the unit (per management) and they wanted a bio hazard box so the defective unit could be sent back.It was unknown what medical intervention was provided for the urinary tract infection follow up via phone on 04mar2021, the unit was making a loud noise at night.Customer noted the unit was not cutting off at night, but realized it had lost suction, which was resolved during troubleshooting and had received a new unit and had no more issues.Customer added that the unit was not leaking from the bottom, but there was leakage where the wick was in place due to the suction issues which resulted in the uti.The uti was treated with prescribed antibiotics.

Event Description

It was reported that the purewick urine collection system might be cutting off at night.No proof except for the patient waking up wet.Per follow up via liberator by phone on (b)(6) 2021, patients stated that the new unit had no suction.Representative did troubleshooting over the phone and the unit had suction.The unit leaked out on the bottom and patient ended up with a urinary tract infection.The old dd15 was working fine and the new unit was purchased for back up.Advised that liberator representative would replace the unit (per management) and they wanted a biohazard box so the defective unit could be sent back.It was unknown what medical intervention was provided for the urinary tract infection.Follow up via phone on (b)(6) 2021, the unit was making a loud noise at night.Customer noted the unit was not cutting off at night, but realized it had lost suction, which was resolved during troubleshooting and had received a new unit and had no more issues.Customer added that the unit was not leaking from the bottom, but there was leakage where the wick was in place due to the suction issues which resulted in the urinary tract infection.The urinary tract infection was treated with prescribed antibiotics.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: d, g, h.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

The reported event was confirmed as a use related since the device meets the specifications.A bd purewick urine collection system collection canister with lid pump tubing and external power cord were returned.There were no cracks or residue within the canister and the stop valve opened and closed freely when shaken.When plugged in there was a light and sound indicative of the pump functioning correctly.An in house collector tubing with an in house elbow connector was used for evaluation as neither were returned.As the device passed during the troubleshooting and meet the requirements during the sample evaluation the reported event was confirmed to be use related.The root cause for this failure mode was due to the user did not follow the instructions and the user forgets to attach the collection lid or unaware that the lid was not fully secured or the user lacks strength or dexterity required.The device was being used for treatment purposes.As the device had met specifications and passed the troubleshooting it appears the reported event occurred due to the misuse of the device.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the device is on but is not suctioning properly: 1.Ensure tubing connections are connected properly.2.Check collector tubing for blockage or flow restriction such as pinched or kinked tubing.3.Ensure overflow stop valve in collection canister lid is open.The valve floats to the top when the collection canister is full.The stop valve may close if the lid or canister is tipped sideways or upside down.Disconnect tubing and gently shake the lid to reset the valve down to the open position.4.Ensure collection canister is sealed with the lid tightly closed.5.Verify suction by disconnecting purewick¿ external catheter from the collector tubing and placing the end of the collector tubing into a cup of water.If water easily flows into the collection canister replace the purewick¿ external catheter." the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the purewick urine collection system might be cut off at night.No proof except for the patient waking up wet.Per follow up via liberator by phone on (b)(6)2021 the patient stated that the new unit had no suction.The representative did troubleshooting over the phone and the unit had suction.The unit leaked out at the bottom and the patient ended up with a urinary tract infection.The old (dd15) was working fine and the new unit was purchased for back up.It was advised that the liberator representative would replace the unit (per management) and they wanted a bio hazard box so the defective unit could be sent back.It is unknown what medical intervention was provided for the urinary tract infection.Per follow up via phone on (b)(6)2021 the unit was making a loud noise at night.The customer noted the unit was not cut off at night but realized it had lost suction which was resolved during troubleshooting and received a new unit and had no more issues.The customer added that the unit was not leaking from the bottom but there was leakage where the wick was in place due to the suction issues which resulted in the urinary tract infection (uti) and was treated with prescribed antibiotics.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM
• Type of Device: PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11468102
• MDR Text Key: 239500727
• Report Number: 1018233-2021-01196
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2021
• Device Catalogue Number: PW100
• Device Lot Number: BMDZPX02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention