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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM; PUREWICK ACCESSORIES REPLACEMENT KIT
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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM; PUREWICK ACCESSORIES REPLACEMENT KIT Back to Search Results
Catalog Number PWKIT03
Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190); Device Handling Problem (3265)
Patient Problems Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 had a urinary tract infection, because the patient stayed wet while using the purewick system.Stated that the unit was not purchased from liberator service.It was unknown what medical intervention was provided.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "improper design and materials used - inadequate fit or seal".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the purewick female external catheter product ifus were found to be adequate based on past reviews.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.H3 other text : the device was not returned.
 
Event Description
It was reported that the patient had a urinary tract infection, because the patient stayed wet while using the purewick system.Stated that the unit was not purchased from liberator service.It was unknown what medical intervention was provided.
 
Event Description
It was reported that the patient had a urinary tract infection, because the patient stayed wet while using the purewick system.Stated that the unit was not purchased from liberator service.It was unknown what medical intervention was provided.Per follow up via phone (b)(6) 2021, customer stated that the rim of the canister was cracked which prevented the canister from having a tight seal and prevented proper suction and resulted to leaking.Also customer stated that the resulted infection was treated with prescribed antibiotics.
 
Manufacturer Narrative
The reported event was confirmed use related based on the reported event and ifu.No sample was returned for evaluation.The failure was likely caused by the use of a defective accessory.A potential root cause for this failure is due to "user does not follow instructions on appropriate canister".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: "use only purewick¿ urine collection system accessories with this device.Incompatible parts or accessories can result in degraded performance and will void the warranty." corrections: b2, d4.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.
 
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Brand Name
PUREWICK URINE COLLECTION SYSTEM
Type of Device
PUREWICK ACCESSORIES REPLACEMENT KIT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10572939
MDR Text Key208107017
Report Number1018233-2020-06142
Device Sequence Number1
Product Code NZU
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
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberPWKIT03
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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