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

Device Problems Increase in Suction (1604); Fitting Problem (2183)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Type  malfunction  

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 wicks do not all fit the patient's hose properly, not allowing suction.The patient had red marks on her stomach from where the loosened connection was suctioning her skin.No medical intervention was reported.

Event Description

It was reported that the wicks do not all fit the patient's hose properly, not allowing suction.The patient had red marks on her stomach from where the loosened connection was suctioning her skin.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to the ¿inadequate component (pump and relief valve) selection".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the purewick urine collection system product ifus were found to be adequate based on past reviews.Correction: h5.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.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY)
• Type of Device: UNKNOWN PUREWICK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10146658
• MDR Text Key: 195233856
• Report Number: 1018233-2020-03771
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1