MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY); UNKNOWN PUREWICK MACHINE

Device Problems Failure to Power Up (1476); Intermittent Loss of Power (4016)

Patient Problem Unspecified Infection (1930)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported via phone call that the purewick urine collection system has worked once but not regularly although the patient did developed an infection in the meantime.Customer stayed in the hospital overnight but it is unknown if the infection was correlated to the device.

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 is 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 device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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 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 via phone call that the purewick urine collection system has worked once but not regularly although the patient did developed an infection in the meantime.Customer stayed in the hospital overnight but it is unknown if the infection was correlated to the device.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY)
• Type of Device: UNKNOWN PUREWICK MACHINE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11615208
• MDR Text Key: 243811027
• Report Number: 1018233-2021-01881
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other