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

Model Number	PWF030
Medical Device Problem Codes	Fluid/Blood Leak (1250); Biocompatibility (2886)
Health Effect - Clinical Codes	Fungal Infection (2419); Tissue Breakdown (2681)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that two pure wick female external catheters were in place for roughly 2-3 hours each time and repeatedly used for urination.Where its sponge made contact, the purewick caused skin breakdown on the labia and a skin lesion on the postpartum labial scar.An infection, maybe yeast, later set in where the skin broke down.Currently the directions for purewick state it should be changed every 8 hours.The nursing staff said it was good for repeated use over that time since the suction dried the urine in the sponge.Repeated use might be causing uric acid to become more concentrated in each use and might be accelerating skin breakdown.Urine was not sterile.Pathogens might be accumulating on the surface.Over the counter monistat used for the acquired infection.The customer stated to reevaluate the catheters and consider limiting it to single use only and to be changed shortly after use, or in the case of leak incontinence, shortly after becoming wet.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to the material surface was rough abrasive or uncomfortable.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indication for use: the purewicktm female external catheter is intended for non-invasive urine output management in female patients.Caution: this product contains dry natural rubber.Contraindications: patients with urinary retention.Warnings: do not use the purewicktm female external catheter with bedpan or any material that does not allow for sufficient airflow.To avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter having frequent episodes of bowel incontinence without a fecal management system in place experiencing skin irritation or breakdown at the site experiencing moderate/heavy menstruation and cannot use a tampon do not use barrier cream on the perineum when using the purewicktm female external catheter.Barrier cream may impede suction.Not recommended for use on patients with a known latex allergy.Proceed with caution in patients who have undergone recent surgery of the external urogenital tract.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Maintain suction until the purewicktm female external catheter is fully removed from the patient to avoid urine back flow.Recommendations: perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.Prior to connecting the purewicktm female external catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial.If the pressure does not increase when the line is covered, verify that the tubing is secured, connected, and not kinked.Ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.Assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days.Setup: 1.Connect the canister to wall suction and set to a minimum of 40 mm hg continuous suction.Always use the minimum amount of suction necessary.If using the drydoctm vacuum station, connect the canister to the unit and turn the unit on.Please consult the drydoctm vacuum station user guide for further information.2.Using standard suction tubing, connect the purewicktm 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 purewicktm 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 purewicktm 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 purewicktm female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewicktm female external catheter directly outward.Ensure suction is maintained while removing the purewicktm 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 purewicktm 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 purewicktm female external catheter." 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.
Event or Problem Description
It was reported that two pure wick female external catheters were in place for roughly 2 to 3 hours each time and repeatedly used for urination.Where its sponge made in contact with the purewick caused the skin breakdown on the labia and a skin lesion on the postpartum labial scar.An infection may be yeast later set in where the skin was broken down.Currently the directions for purewick state it should be changed for every 8 hours.The nursing staff stated that the device was good for repeated use over the time since the suction dries the urine in the sponge.Repeated use may be causing the uric acid to become more concentrated in each use and may be accelerating the skin breakdown.The urine was not sterile.The pathogens may be accumulating on the surface.Over the counter monistat used for the acquired infection.It was noted that the catheters need to be reevaluated and consider limiting it to single use only and to be changed shortly after the use or in the case of leak incontinence shortly after becoming wet.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11487622
• Report Number: 1018233-2021-01298
• Device Sequence Number: 3397806
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PWF030
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention