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

Model Number PW100

Device Problem Nonstandard Device (1420)

Patient Problem Shock (2072)

Event Date 08/31/2022

Event Type  Injury  

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 patient felt shock when the purewick urine collection system was on the patient.The patient had a pacemaker and afraid of being shocked.They stated that they read the instructions and it warmed of being shocked with the purewick urine collection system.The patient had been using this product for less than 90 days.It was unknown if the device contributed to the shock at this time and medical intervention was unknown.

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 was 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: "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.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." it also states "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." it also states "do not use the device if it is damaged or defective, including, but not limited to the following: cracks separated housing not suctioning properly or no suction damaged power cord." 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 patient felt shock when the purewick urine collection system was on the patient.The patient had a pacemaker and afraid of being shocked.They stated that they read the instructions and it warmed of being shocked with the purewick urine collection system.The patient had been using this product for less than 90 days.It was unknown if the device contributed to the shock at this time and medical intervention was unknown.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15370853
• MDR Text Key: 299382529
• Report Number: 1018233-2022-06964
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 11/29/2022
• 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