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 BARDEX® LUBRICATH® FOLEY 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 BARDEX® LUBRICATH® FOLEY CATHETER Back to Search Results
Model Number 0165L16
Device Problems Inaccurate Flow Rate (1249); Obstruction of Flow (2423)
Patient Problems Pain (1994); Urinary Retention (2119)
Event Type  malfunction  
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 catheter did not drain unless it was fully stretched to the foot of the bed and the tubing from the statlock was held parallel to the patient.The complainant reported that this resulted in "inaccurate bolus for fluid correction on patients and pain due to the bladder becoming full while the catheter is in place." the complainant noted that 500ml of urine was emptied after stretching the tubing.The meter bag that was being used was reportedly changed to a "regular" bag and the issue was resolved.No medical intervention was reported.
 
Event Description
It was reported that the catheter did not drain unless it was fully stretched to the foot of the bed and the tubing from the statlock was held parallel to the patient.The complainant reported that this resulted in "inaccurate bolus for fluid correction on patients and pain due to the bladder becoming full while the catheter is in place." the complainant noted that 500ml of urine was emptied after stretching the tubing.The meter bag that was being used was reportedly changed to a "regular" bag and the issue was resolved.No medical intervention was reported.
 
Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deteriorations prior to use." 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
BARDEX® LUBRICATH® FOLEY CATHETER
Type of Device
LUBRICATH
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8712322
MDR Text Key148831979
Report Number1018233-2019-03207
Device Sequence Number1
Product Code EZC
UDI-Device Identifier00801741017483
UDI-Public(01)00801741017483
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model Number0165L16
Device Catalogue Number0165L16
Device Lot NumberNGCZ2722
Was Device Available for Evaluation? No
Date Manufacturer Received07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-