MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN PUREWICK HOME CARE DISPOSABLE

Device Problems Decrease in Suction (1146); Suction Failure (4039)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that the patient thought that the purewick urine collection system did not have enough suction, sometimes it did not suck it up at all and sometimes it goes in the tube past the wand.They were concerned because the patient had parkinsons, cancer and were in jeopardy of getting an infection again if the urine gets inside the wound on their tailbone.The patient had already been to the hospital because of an infection due to the urine getting inside the wound.Customer had been experiencing issues for a while, at least the last week and a half.They would like to have this issue taken care of to help prevent further infections and ensure the product purchased works.Per customer on 16oct2023, it was reported that the device was leaking which made it easy for urine to get inside the wound on the tailbone to cause the patient to get an infection.Patient had to go to the hospital to receive iv antibiotics and injection antibiotics.Customer states they were sent a replacement device that was working well and patient was recovering from the infection.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to "dimensions not specified correctly and/or improper materials used assembly collapses under vacuum".The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.

Event Description

It was reported that the patient thought that the purewick urine collection system did not have enough suction, sometimes it did not suck it up at all and sometimes it goes in the tube past the wand.They were concerned because the patient had parkinsons, cancer and were in jeopardy of getting an infection again if the urine gets inside the wound on their tailbone.The patient had already been to the hospital because of an infection due to the urine getting inside the wound.Customer had been experiencing issues for a while, at least the last week and a half.They would like to have this issue taken care of to help prevent further infections and ensure the product purchased works.Per customer on 16oct2023, it was reported that the device was leaking which made it easy for urine to get inside the wound on the tailbone to cause the patient to get an infection.Patient had to go to the hospital to receive iv antibiotics and injection antibiotics.Customer states they were sent a replacement device that was working well and patient was recovering from the infection.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to "inadequate design, inadequate system design".The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.

• Brand Name: UNKNOWN PUREWICK HOME CARE DISPOSABLE
• Type of Device: UNKNOWN PUREWICK HOME CARE DISPOSABLE
• 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: 17975071
• MDR Text Key: 326151692
• Report Number: 1018233-2023-07599
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (y/n): Y
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female