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

Model Number PW100

Device Problem Biocompatibility (2886)

Patient Problem Tachycardia (2095)

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced heart palpitations when the purewick urine collection system was running, if not urinating actively.The patient felt drained after using the device, had no heart issues and only used oxygen and purewick.The patient had been using the product more than 90 days.And the patient was advised to consult with a physician.It was unknown what medical intervention was provided for heart palpitations per additional information from liberator, original kit was purchased on 08jun2021.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 patient experienced heart palpitations when the purewick urine collection system was running, if not urinating actively.The patient felt drained after using the device, had no heart issues and only used oxygen and purewick.The patient had been using the product more than 90 days.And the patient was advised to consult with a physician.It was unknown what medical intervention was provided for heart palpitations.Per additional information from liberator, original kit was purchased on 08jun2021.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate component selection".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "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.Intended users the purewick¿ urine collection system is intended to be operated by: user/patient caregiver/healthcare professional all functions can be safely performed by the individuals above.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: 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.Contact customer support at 1-888-201-1586 if any damage is observed.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 and contact customer support at 1-888-201-1586.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 and is not covered under the warranty.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 and will void the warranty.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 and will void the warranty.Do not place purewick¿ urine collection system or its cord across walkways creating a tripping hazard.For pw200: the battery cells used in this device may present a fire or chemical hazard.To minimize the risk of damaging the battery inside the purewick¿ urine collection system, do not use the device outside the indicated operating temperature range of 41°f - 104°f (5°c - 40°c).The battery is not intended to be replaced; replacement could result in a hazard.Initial setup 1.Inspect the package for damage.If any damage is noticed, contact customer support at 1-888-201-1586 immediately.2.Carefully remove all contents from the package, including the packing material and inspect prior to use.If any damage is noticed, contact customer support at 1-888-201-1586 immediately.3.Place the purewick¿ urine collection system (a) next to the bed or chair where it will be used.It must be close enough for the collector tubing with elbow connector (g) to easily reach the user and should be placed on a stable, even surface.For optimal results, position the purewick¿ urine collection system either on the floor or as close to the floor as your facility¿s protocol will allow.Note: the purewick¿ urine collection system should be stationary while in use.Device is not designed to be used while in transport.Caution: avoid creating a tripping hazard with the collector tubing or power cord.1.Plug the purewick¿ urine collection system power cord into device outlet (b) and into an a/c power outlet.Note: the device should be positioned for easy access to the a/c inlet and power cord.Note: make sure the power switch is turned off before connecting the power cord.Battery power operation (pw200 only) the built-in battery recharges any time the device is plugged into an outlet.To fully charge the battery, the system must be plugged in for 12 hours.The battery will supply 8 hours of backup power before requiring recharging.The purewick¿ urine collection system remains fully functional while the device is recharging.Initial setup 1.Inspect the package for damage.If any damage is noticed, contact customer support at 1-888-201-1586 immediately.2.Carefully remove all contents from the package, including the packing material and inspect prior to use.If any damage is noticed, contact customer support at 1-888-201-1586 immediately.3.Place the purewick¿ urine collection system (a) next to the bed or chair where it will be used.It must be close enough for the collector tubing with elbow connector (g) to easily reach the user and should be placed on a stable, even surface.For optimal results, position the purewick¿ urine collection system either on the floor or as close to the floor as your facility¿s protocol will allow.Note: the purewick¿ urine collection system should be stationary while in use.Device is not designed to be used while in transport.Caution: avoid creating a tripping hazard with the collector tubing or power cord.1.Plug the purewick¿ urine collection system power cord into device outlet (b) and into an a/c power outlet.Note: the device should be positioned for easy access to the a/c inlet and power cord.Note: make sure the power switch is turned off before connecting the power cord.Battery power operation (pw200 only) the built-in battery recharges any time the device is plugged into an outlet.To fully charge the battery, the system must be plugged in for 12 hours.The battery will supply 8 hours of backup power before requiring recharging.The purewick¿ urine collection system remains fully functional while the device is recharging.1.Place the collection canister (c) in the purewick¿ urine collection system base and press down firmly on the lid making sure the lid is sealed.Optional (prior to sealing canister lid): while operating the purewick¿ urine collection system, ammonia odor for up to 1800 ml of urine can be eliminated by adding 2 teaspoons (10 grams) of vitamin c (ascorbic acid) powder into the collection canister before use.At least 99.93% of pure vitamin c (ascorbic acid) is recommended.If using the privacy cover (j), slip privacy cover onto canister (similar to a coffee cup sleeve) prior to placing canister into the base.Attach the pump tubing (d) to the purewick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.1.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).Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick¿ urine collection system.1.Turn on the purewick¿ urine collection system by pressing the on/off switch.The purewick¿ urine collection system is working when the switch lights up green and the device makes a soft humming sound.The system is now ready for use.Operating instructions: 1.After the purewick¿ urine collection system has been set up, place the purewick¿ external catheter according to the purewick¿ external catheter¿s instructions for use.2.When the canister is ready to be emptied, remove the purewick¿ external catheter according to the purewick¿ external catheter¿s instructions for use and throw away.Note: keep the purewick¿ urine collection system on to make sure all urine has been drawn out of the collector tubing and into the collection canister before removing the purewick¿ external catheter.Note: although the canister can hold up to 2000cc (ml), to prevent overflow empty urine from the collection canister regularly or before volume reaches 1800cc (ml).1.Turn off the purewick¿ urine collection system by pressing the on/off switch.Disconnect the a/c power cord from the power outlet and from the device.Disconnect collector tubing and pump tubing from the canister.2.Lift collection canister from purewick¿ urine collection system.Do not lift canister by the lid.Take canister into an area appropriate for disposal e.G.A bathroom, carefully remove the lid, and dispose of urine in a proper receptacle e.G.A toilet or according to facility protocol.If using a privacy cover and it gets wet, remove and discard.3.Clean collector tubing, pump tubing, canister, purewick¿ urine collection system, and power cord according to cleaning instructions in the cleaning and maintenance section.1.Reassemble the purewick¿ urine collection system according to the initial setup instructions when the system is ready to be reused.When the purewick¿ urine collection system is not in use, unplug the power cord from its outlet.Make sure the unit is cleaned and disinfected prior to storage.Do not store when parts are wet or damp.Cleaning and maintenance: inspect the purewick¿ urine collection system and accessories for damage or wear prior to use and replace as necessary.Do not attempt to open or dismantle the purewick¿ urine collection system.This may affect performance, create a potential safety hazard, cause personal injury, and will void the warranty.Always turn off the device and disconnect from power source prior to cleaning.The privacy cover components are single use only and should not be cleaned or disinfected.Replacing canister and tubing: replace the canister and tubing for each patient per facility protocol or at least every 60 days, whichever is sooner.If you notice any of the following, replace immediately: ¿ canister or tubing has residual urine build-up ¿ canister or tubing appear cloudy ¿ canister or tubing appear discolored ¿ canister becomes cracked ¿ tubing becomes torn ¿ purewick¿ external catheter no longer securely connects to collector tubing failure to clean and/or replace accessories may affect the performance of the system.The useful life of the collection canister and tubing is 60 days.¿ 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.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12821017
• MDR Text Key: 280831774
• Report Number: 1018233-2021-07278
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• 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