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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
Model Number PWFX30
Device Problem Positioning Failure (1158)
Patient Problem Rash (2033)
Event Date 08/12/2022
Event Type  Injury  
Event Description
It was reported that the patient experienced irritation with the purewick female external catheters.The patient did not purchase the purewick urine collection system or purewick female external catheters through us.Note sure if it was in fact purewick female external catheter they used but they got irritation.Per follow up via phone on 12aug2022, it was reported that the nurses were having placement issues with the purewick female external catheters and the wicks were causing rashes and was prescribed a cream by the doctor for the rash.Inquired about if latex was in the products and inquirer explained the difference between latex and latex free and patient said that they were going to get the nursing home to order the latex free.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to "dimensions not specified correctly and/or improper materials used".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter.Recommendations: 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 maybe useful for securing the purewicktm female external catheter for some patients." the device was not returned.
 
Event Description
It was reported that the patient experienced irritation with the purewick female external catheters.The patient did not purchase the purewick urine collection system or purewick female external catheters through us.Note sure if it was in fact purewick female external catheter they used but they got irritation.Per follow up via phone on 12aug2022, it was reported that the nurses were having placement issues with the purewick female external catheters and the wicks were causing rashes and was prescribed a cream by the doctor for the rash.Inquired about if latex was in the products and inquirer explained the difference between latex and latex free and patient said that they were going to get the nursing home to order the latex free.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15265191
MDR Text Key298298171
Report Number1018233-2022-06604
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 Initial,Followup
Report Date 10/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberPWFX30
Device Catalogue NumberPWFX30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2022
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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