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

Catalog Number PW100

Device Problem Increase in Suction (1604)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate component(pump and relief valve) selection".A device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: "indications for use the purewick¿ urine collection system is to be used with purewick¿ external catheters which are intended for non-invasive urine output management.Contraindications for use do not use the purewick¿ urine collection system with purewick¿ external catheters on individuals with urinary retention.Safety and warnings always unplug purewick¿ urine collection system before cleaning or when not in use.Do not immerse the purewick¿ urine collection system in water.As with most electrical devices, electrical parts in this system are electrically live even when the power is off.To reduce the risk of electric shock, if the purewick¿ urine collection system falls into water, unplug immediately.Do not reach into the water to retrieve it.Warning: contains small parts that may cause choking.Keep out of reach of children.Keep cords and tubing out of the reach of children to avoid the risk of strangulation.Discontinue use if an allergic reaction occurs.Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas.Warning: this device should not be used in oxygen rich environments or in conjunction with flammable anesthetics.If the purewick¿ urine collection system is dropped or tipped over spilling urine, unplug the unit and carefully inspect for loose or damaged parts before resuming use.The pump tubing connecting the purewick¿ urine collection system to the collection canister may experience light condensation inside the tube.This is not unusual and does not affect function.However, if urine or water has streamed into the pump, discontinue use.Although the canister can hold up to 2000cc (ml), the urine should be emptied regularly from the collection canister before volume reaches 1800cc (ml).Failure to empty canister before urine overflow may cause damage to the purewick¿ urine collection system.It is important that the port connections be connected correctly for proper operation of the purewick¿ urine collection system.Use of this equipment next to or stacked with other equipment should be avoided because it could result in improper operation.If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.Portable radio frequency (rf) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30cm) to any part of the purewick¿ urine collection system, including cables specified by the manufacturer.Otherwise, degradation of the performance of this equipment could result.Use only purewick¿ urine collection system accessories with this device.Incompatible parts or accessories can result in degraded performance.Do not use accessories past expiration date indicated on package labeling.Use only the purewick¿ urine collection system a/c power cord with the device.Use of an alternate consumer style a/c power adapter or an extension cord may cause damage to device and electrical shock or injury.Do not place purewick¿ urine collection system or its cord across walkways creating a tripping hazard." 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 suction of the purewick urine collection system from the purewick at home system was too strong.

• 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: 17875670
• MDR Text Key: 324973485
• Report Number: 1018233-2023-07180
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185342
• UDI-Public: (01)00801741185342
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• 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