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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER; HYDROGEL CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER; HYDROGEL CATHETER Back to Search Results
Model Number 365712
Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 02/21/2019
Event Type  malfunction  
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 client's spouse contacted the home health office to inform them that the catheter had fallen out.The home care nurse attended the client and found the catheter out of the client with only part of the balloon.The balloon appeared to have ruptured and was not complete, which indicated that fragments of the balloon were retained in client's bladder.
 
Manufacturer Narrative
The reported event was confirmed as cause unknown.The evaluation found a balloon sac burst.The sample was evaluated under a microscope and no conditions were found that could be associated with the reported event.The exact cause could not be determined.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: ¿single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use.".
 
Event Description
It was reported that the clients spouse contacted the home health office to inform them that the catheter had fallen out.The home care nurse attended the client and found the catheter out of the client with only part of the balloon.The balloon appeared to have ruptured and was not complete, which indicated that fragments of the balloon were retained in client's bladder.
 
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: ¿ "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." correction: concomitant medical products and device evaluated by mfr.
 
Event Description
It was reported that the client's spouse contacted the home health office to inform them that the catheter had fallen out.The home care nurse attended the client and found the catheter out of the client with only part of the balloon.The balloon appeared to have ruptured and was not complete, which indicated that fragments of the balloon were retained in client's bladder.
 
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Brand Name
BARD® LUBRICATH® FOLEY CATHETER
Type of Device
HYDROGEL CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8433023
MDR Text Key139232206
Report Number1018233-2019-01419
Device Sequence Number1
Product Code EZC
UDI-Device Identifier00801741077722
UDI-Public(01)00801741077722
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 06/26/2019
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? Yes
Device Operator Lay User/Patient
Device Expiration Date01/01/2021
Device Model Number365712
Device Catalogue Number365712
Device Lot Number6AJ7110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Initial Date Manufacturer Received 02/28/2019
Initial Date FDA Received03/19/2019
Supplement Dates Manufacturer Received04/16/2019
06/25/2019
Supplement Dates FDA Received05/06/2019
06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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