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

Model Number PW100

Device Problem Overheating of Device (1437)

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

Event Date 04/18/2023

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that the purewick urine collection system has no suctioning.The purewick urine collection system was also overheating and making a loud sound.Patients' caregiver does not feel as if it was safe for the patient to use.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inadequate system design".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: " 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.When the purewick¿ urine collection system has been stored in a very cold environment (down to -13°f or -25°c), please allow the device to sit for approximately 90 minutes at room temperature (approximately 68°f or 20°c) before use.When the purewick¿ urine collection system has been stored in a very warm environment (up to 158°f or 70°c), please allow the device to sit for approximately 90 minutes at room temperature (approximately 68°f or 20°c) before use." 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 purewick urine collection system has no suctioning.The purewick urine collection system was also overheating and making a loud sound.Patients' caregiver does not feel as if it was safe for the patient to use.

• 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: 16886707
• MDR Text Key: 314751308
• Report Number: 1018233-2023-03250
• 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: 06/16/2023

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 Model Number: PW100
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/22/2023
• 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