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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
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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL Back to Search Results
Catalog Number PWF030
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the patient stated she had been using the purewick for 28 days, and got 2 urinary tract infections.She also stated she didn't normally get them.It was unknown if the patient received intervention for the uti.
 
Manufacturer Narrative
The reported event was confirmed as use-related.The customer stated that the purewick was used for 28 days.According to the ifu, "replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood." a potential root cause could be due to the "user unaware of time limitation or forgets the patient is using the device." as no sample was returned it is unknown if the device met specifications; however, based on the ifu there appears to be to use-related relationship between the reported event and the device.Based on the event ,it appears that the device was used for treatment.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: ¿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 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.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.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." 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 Description
It was reported that the patient stated she had been using the purewick for 28 days, and got 2 urinary tract infections.She also stated she didn't normally get them.It was unknown if the patient received intervention for the uti.
 
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Brand Name
PUREWICK FEMALE EXTERNAL
Type of Device
PUREWICK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9607772
MDR Text Key178122287
Report Number1018233-2020-00438
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741143083
UDI-Public(01)00801741143083
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 02/28/2020
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 NumberPWF030
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/30/2019
Initial Date FDA Received01/20/2020
Supplement Dates Manufacturer Received02/25/2020
Supplement Dates FDA Received02/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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