MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

Catalog Number PWFX30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient¿s vagina started swelling up with purewick female external catheter, and they stopped using purewick.No medical intervention was reported.Per follow up via phone on 14-mar-2024, customer reported that the patient passed away about a week and half ago, so the purewick was no longer needed.Per clinical follow up via phone on 18-mar-2024, the customer confirmed they stopped using the purewick device about a month before the patient passed away because the patient had experienced swelling, soreness, and irritation.The patient was seen by their doctor and prescribed cream and powder.The customer additionally reported some of the wicks were not suctioning.They went through troubleshooting and the device was suctioning, but the wicks would not suction once attached.The patient had stopped eating and drinking a few days prior to death, and they passed away on (b)(6) 2024 due to congestive heart failure (chf) and atrial fibrillation.The customer additionally stated the patient¿s death was unrelated to the purewick device.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be ¿inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable".However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "instructions for use setup: 1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.If using the purewick¿ urine collection system, connect the canister to the unit and turn the unit on.Please consult the purewick¿ urine collection system user guide for further information.2.Using standard suction tubing, connect the purewick¿ female external catheter to the collection canister.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.With soft gauze side facing patient, align distal end of the purewick¿ female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewick¿ female external catheter is positioned.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Removal: 5.To remove the purewick¿ female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewick¿ female external catheter directly outward.Ensure suction is maintained while removing the purewick¿ female external catheter.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Maintenance: 6.Replace the purewick¿ female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewick¿ female external catheter." 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¿s vagina started swelling up with purewick female external catheter, and they stopped using purewick.No medical intervention was reported.Per follow up via phone on 14-mar-2024, a family member reported that the patient passed away about a week and half ago, so the purewick was no longer needed.Per clinical follow up via phone on (b)(6) 2024 the patient¿s daughter confirmed they stopped using the purewick device about a month before the patient passed away because the patient had experienced swelling, soreness, and irritation.The patient was seen by the doctor and prescribed cream and powder.The patient¿s daughter additionally reported some of the wicks were not suctioning.They went through troubleshooting and the device was suctioning, but the wicks would not suction once attached.The patient had stopped eating and drinking a few days prior to death, and the patient passed away on (b)(6) 2024 due to congestive heart failure (chf) and atrial fibrillation.The patient¿s daughter additionally stated the patient¿s death was unrelated to the purewick device.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: PUREWICK FEMALE EXTERNAL CATHETER
• 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: 18949816
• MDR Text Key: 338246368
• Report Number: 1018233-2024-01505
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• 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: 05/10/2024

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/13/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female