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 Problem Abrasion (1689)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable ".The lot number is unknown; therefore, the device history record could not be reviewed.The labeling is found to be adequate.Purewick female external catheter: instructions for use: 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 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.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.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.Indications for use: the purewick¿ women's external catheter is designed for non-invasive control of urine output in female patients.Contraindications: ¿ patients with urinary retention warnings: ¿ do not use the purewick¿ women's external catheter with a potty or any material that does not allow sufficient airflow.¿ to avoid possible injury to the skin, never push against the skin or pull on the external catheter to purewick¿ women during placement or removal.¿ never insert the purewick¿ women's external catheter into the vagina, anal canal, or other body cavities.¿ discontinue use if an allergic reaction occurs.Precautions: ¿ not recommended for patients who: - are agitated, aggressive, or uncooperative and can remove the external catheter to purewick¿ women.- suffer frequent episodes of bowel incontinence without a fecal management system in place.- experience skin irritation or breakdown at the site.- experience moderate/severe menstruation and are unable to use a tampon.¿ do not use protective cream on the perineum when using the purewick¿ women's external catheter recommendations: ¿ perform each step with a hygienic technique.At home, wash your hands thoroughly before to place the device.¿ before attaching the purewick¿ women's external catheter to the suction inlet tube of the hospital, check the suction function by covering the open end of the suction tube with one hand and look at the pressure gauge.If the pressure does not increase when you plug the line, check that the tubing is secured, connected, and crease-free.The correct and tight placement of the purewick¿ women's external catheter between the lips and buttocks it will keep it in place in most patients.In some patients, the underwear of a socket can be helpful in securing the purewick¿ women's external catheter.¿ assess device placement and patient skin at least every 2 hours.¿ replace the purewick¿ women's external catheter every 8 to 12 hours or if soiled with feces or blood.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 got a cut using the purewick female external catheter on labia and had stopped using it.Per customer follow up received on 30jan2024 it was reported that the cut the customer received from the wick was treated with ointment and patient was given a prescription antibiotic to prevent any infection.No additional information is available and no sample available.No further follow ups required.

• 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: 18696540
• MDR Text Key: 335261248
• Report Number: 1018233-2024-00686
• Device Sequence Number: 1
• Product Code: NZU
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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
• Date Manufacturer Received: 01/30/2024
• 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