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

Model Number PW100

Device Problem Increase in Suction (1604)

Patient Problem Blister (4537)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

It was reported that the purewick urine collection system was creating a way too much suction so it was causing blisters on the patient.The patient stated that they had already consulted a doctor.The representative recommended the patient discontinued use of that purewick urine collection system.The patient had been using this product for more than 90 days.No medical intervention was reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was unconfirmed because the device meets specifications.A bd purewick urine collection system, pump tubing, collector tubing with elbow connector, collection canister with lid, and external power cord were returned.There were no cracks present.There was no residue present in the canister but there was slight residue in the collector tubing and pump tubing.The stop valve was working properly.There was light and sound indicating function.The suction amount and rate of suction were not more than average so suction strength was normal.No root cause could be found because the reported event was unconfirmed.The dhr review was not required as the investigation was unconfirmed.Based on the results of the investigation no additional action is required at this time.As the reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.

Event Description

It was reported that the purewick urine collection system was creating a way too much suction so it was causing blisters on the patient.The patient stated that they had already consulted a doctor.The representative recommended the patient discontinued use of that purewick urine collection system.The patient had been using this product for more than 90 days.No medical intervention was reported.

• 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: 15494190
• MDR Text Key: 303920384
• Report Number: 1018233-2022-07483
• 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: 02/16/2023

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 Expiration Date: 01/03/2023
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Device Lot Number: BMFPPX06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2022
• 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