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

Catalog Number PW200

Device Problems Patient Device Interaction Problem (4001); Suction Failure (4039)

Patient Problem Fall (1848)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 customer wanted a full refund for the purewick urine collection system because it was defective, and she did not want it.The customer placed an initial order online for a purewick urine collection system (pw200) and purewick female external catheter (pwfx30) on (b)(6) 2023.The order was received on (b)(6)2023, and the customer had the purewick device for 48 hours.The customer reported that the patient was hurt while using the device, and she stated the patient may never walk again due to this.The customer stated the patient woke up soaked in urine, so she tried to get the patient to the bathroom to bathe her.On their way to the bathroom, the patient fell and was injured.Paramedics were called and assisted with picking up the patient, but no additional medical intervention was reported.The customer stated she knew how to use the device and refused to attempt troubleshooting.The liberator representative informed the customer they would need to troubleshoot the issue first and the device would be replaced, but they do not offer refunds.Per bd follow up via phone on (b)(6) 2023, the patient¿s daughter confirmed purewick system failed to work two (2) nights in a row.On the second morning, the patient was covered in urine, so the patient¿s daughter was assisting the patient out of bed for a shower when the patient fell.She additionally stated the patient was never able to get out of bed again.The daughter explained that she did not want to troubleshoot the issue or a replacement device; she wanted a refund.Per additional information received via email from lms on (b)(6) 2023, the lms representative contacted the patient¿s daughter to discuss the return request.After explaining the policy, the patient¿s daughter was transferred to the lms customer service supervisor.The patient¿s daughter initially informed the supervisor that she was not blaming the patient¿s death on the device.However, after the supervisor informed her that she would not receive a refund, the customer then alleged that the patient¿s death was related to the device.She additionally stated the device did not work, and it was the reason the patient was miserable to the end.The patient¿s daughter reported that the purewick machine killed the patient or at least made her suffer.She additionally demanded a full refund.The supervisor explained the return and refund policy, and the patient¿s daughter stated she would be pursuing further actions.Per clarification email received from lms on (b)(6) 2023, it was reported that the patient was deceased.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate system design".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "attach the pump tubing (d) to the purewick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.Attach the collector tubing (g) to the connector port (h) on the collection canister lid.Connect the other end of the collector tubing securely to a purewick¿ external catheter (i)".[note the letters correlate to a diagram within the ifu].Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick¿ urine collection system."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".H11: section a through f - the information provided by bd represents all 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.H3 other text: the device was not returned.

Event Description

It was reported that the customer wanted a full refund for the purewick urine collection system because it was defective, and she did not want it.The customer placed an initial order online for a purewick urine collection system (pw200) and purewick female external catheter (pwfx30) on (b)(6) 2023.The order was received on 12-july-2023, and the customer had the purewick device for 48 hours.The customer reported that the patient was hurt while using the device, and she stated the patient may never walk again due to this.The customer stated the patient woke up soaked in urine, so she tried to get the patient to the bathroom to bathe her.On their way to the bathroom, the patient fell and was injured.Paramedics were called and assisted with picking up the patient, but no additional medical intervention was reported.The customer stated she knew how to use the device and refused to attempt troubleshooting.The liberator representative informed the customer they would need to troubleshoot the issue first and the device would be replaced, but they do not offer refunds.Per bd follow up via phone on 20-july-2023, the patient¿s daughter confirmed purewick system failed to work two (2) nights in a row.On the second morning, the patient was covered in urine, so the patient¿s daughter was assisting the patient out of bed for a shower when the patient fell.She additionally stated the patient was never able to get out of bed again.The daughter explained that she did not want to troubleshoot the issue or a replacement device; she wanted a refund.Per additional information received via email from lms on 20-july-2023, the lms representative contacted the patient¿s daughter to discuss the return request.After explaining the policy, the patient¿s daughter was transferred to the lms customer service supervisor.The patient¿s daughter initially informed the supervisor that she was not blaming the patient¿s death on the device.However, after the supervisor informed her that she would not receive a refund, the customer then alleged that the patient¿s death was related to the device.She additionally stated the device did not work, and it was the reason the patient was miserable to the end.The patient¿s daughter reported that the purewick machine killed the patient or at least made her suffer.She additionally demanded a full refund.The supervisor explained the return and refund policy, and the patient¿s daughter stated she would be pursuing further actions.Per clarification email received from lms on 21-july-2023, it was reported that the patient was deceased.Additional follow up information was via email from the legal team on 21-aug-2023.The patient¿s daughter reported that the purewick device did not work at all, and it was not absorbing any liquid.She found the patient soaked in urine, so she assisted the patient out of bed and removed her soiled clothing.As they were walking to the shower, there was urine on the floor due to the device not absorbing urine.The patient slipped in the urine and fell, and the daughter¿s husband helped pick the patient up off the floor.The patient¿s daughter reported that the patient never walked again after that, and ultimately passed away.

• 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
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17509145
• MDR Text Key: 320878233
• Report Number: 1018233-2023-06015
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185359
• UDI-Public: (01)00801741185359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PW200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female