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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM
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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM Back to Search Results
Model Number PW200
Device Problems Inadequate Instructions for Healthcare Professional (1319); Missing Information (4053)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the instructions regarding purewick urine collection system setup and use contained in the blue folder were not demonstrated the correct way and did not match other included paper work or the videos.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to "missing instructions".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: "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: 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.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.To reduce the risk of electrical shock or injury, do not disassemble this unit.No modification of this equipment is allowed." correction: h5.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.H3 other text : the device was not returned.
 
Event Description
It was reported that the instructions regarding purewick urine collection system setup and use contained in the blue folder were not demonstrated the correct way and did not match other included paper work or the videos.It was reported that the everything was working fine in purewick urine collection system and problem was the instructions had a picture in them showing a terminal connection hookup on the bottom of the cannister when it was actually on the top.It was confusing and wanted to let the company know so they could change it.
 
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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 GA 30014
MDR Report Key10469654
MDR Text Key206105573
Report Number1018233-2020-05567
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741185359
UDI-Public(01)00801741185359
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 12/22/2020
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 Model NumberPW200
Device Catalogue NumberPW200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/07/2020
Initial Date FDA Received08/29/2020
Supplement Dates Manufacturer Received12/01/2020
Supplement Dates FDA Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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