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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER Back to Search Results
Catalog Number PWFX30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urinary Tract Infection (2120)
Event Date 01/24/2024
Event Type  Injury  
Event Description
It was reported that the patient could not use the purewick female external catheter because they kept getting urinary tract infections when using and needed a fecal transplant was doing much better now.
 
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.
 
Event Description
It was reported that the patient could not use the purewick female external catheter because they kept getting urinary tract infections when using and needed a fecal transplant was doing much better now.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible".A device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿purewick female external catheter 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.External use only indication for use: the purewick¿ female external catheter is intended for non-invasive urine output management in female patients.Contraindications: patients with urinary retention warnings: do not use the purewick¿ 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 purewick¿ female external catheter against the skin during placement or removal.Never insert the purewick¿ 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 purewick¿ 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 purewick¿ female external catheter.Barrier cream may impede suction.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 purewick¿ female external catheter.Maintain suction until the purewick¿ female external catheter is fully removed from the patient to avoid urine backflow.Recommendations: perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.Prior to connecting the purewick¿ 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 purewick¿ female external catheter remains in the correct position after turning the patient.Remove the purewick¿ female external catheter prior to ambulation.Properly placing the purewick¿ female external catheter snugly between the labia and gluteus holds the purewick¿ female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick¿ female external catheter for some patients.Assess device placement and patient¿s skin at least every 2 hours.Replace the purewick¿ 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.¿ 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.
 
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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 Key18694797
MDR Text Key335247379
Report Number1018233-2024-00677
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741189050
UDI-Public(01)00801741189050
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Followup
Report Date 03/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberPWFX30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2024
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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