Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN PUREWICK DISPOSABLE; UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN PUREWICK DISPOSABLE; UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER Back to Search Results
Model Number PW100
Device Problems Biocompatibility (2886); Misassembly by Users (3133)
Patient Problem Urinary Tract Infection (2120)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the purewick urine collection system was not working.Also stated patient voided at least 3 times last night but the collection jar only had a little urine collected.Per troubleshooting the unit passed water test with and without wick.Thought patient must be voiding a lot of urine, but was not and only a little trickle.Patient had a urinary tract infection.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.
 
Event Description
It was reported that the purewick urine collection system was not working.Also stated that the patient voided at least 3 times last night but the collection jar only had a little urine collected.Per troubleshooting the unit passed the water test with and without wick.The patient thought that it must be voiding a lot of urine but was not and only a little trickle.The patient had a urinary tract infection.It is unknown whether the device contributed to the urinary tract infection and what medical intervention provided was unknown.
 
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 purewick urine collection system was not working.Also stated that the patient voided at least 3 times last night but the collection jar only had a little urine collected.Per troubleshooting the unit passed the water test with and without wick.The patient thought that it must be voiding a lot of urine but was not and only a little trickle.The patient had a urinary tract infection.It is unknown whether the device contributed to the urinary tract infection and what medical intervention provided was unknown.Per follow up made (b)(6) 2020, the customers son and his wife indicated there is no issue with the device, it works great.The patient just does not urinate enough.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be that material surface is rough, abrasive or uncomfortable.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 disposable 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN PUREWICK DISPOSABLE
Type of Device
UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key10816731
MDR Text Key215511486
Report Number1018233-2020-20852
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741185342
UDI-Public(01)00801741185342
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberPW100
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-