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

Model Number PW100

Device Problem Increase in Suction (1604)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was having problems with the placement of the purewick female external catheter.Per follow up call on (b)(6) 2021 the customer stated that they returned everything because the machine did not work out for the patient and they tried to use it three times but each time it caused the patient to bleed.No medical intervention was required because they were able to handle it.It was noted that the machine was suctioning the patients skin and stated that the patient had a thinner skin.

Manufacturer Narrative

The reported event is unconfirmed as the device met specifications.The bd purewick urine collection system, collection canister with lid, pump tubing, collector tubing, elbow connector and external power cord were returned.No cracks or residues were noted in the canister lid or tubing.When the lid was shaken, the overflow valve moved freely and was not stuck in place.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a label/packaging 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.

Event Description

It was reported that the patient was having problems with the placement of the purewick female external catheter.Per follow up call on 18jun2021 the customer stated that they returned everything because the machine did not work out for the patient and they tried to use it three times but each time it caused the patient to bleed.No medical intervention was required because they were able to handle it.It was noted that the machine was suctioning the patients skin and stated that the patient had a thinner skin.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12218284
• MDR Text Key: 263213008
• Report Number: 1018233-2021-04446
• 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): Y
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/05/2022
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Device Lot Number: BMEYPX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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