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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER SILICONE COATED
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C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER SILICONE COATED Back to Search Results
Catalog Number 123516A
Device Problem Component Misassembled (4004)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
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 foley catheter did not have a sample port to get a clean catch urine.Also when the customer opened the foley catheter package, it was found that the catheter was not sleeved and was just laying in the box.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e.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 foley bag did not have a sample port to get a clean catch urine.Also when the customer opened the foley catheter package it was found that the catheter was not sleeved and just laying in the box.Per follow up on 04mar2021 the patient developed a urinary tract infection since using the catheter from the foley tray but was uncertain whether it was caused by the catheter.The patient was treated with prescribed antibiotics.Also stated there was no sample port on the bag or tubing even though it was mentioned that it contains a sample port.Also the customer provided quantity as 4.
 
Event Description
It was reported that the foley bag did not have a sample port to get a clean catch urine.Also when the customer opened the foley catheter package it was found that the catheter was not sleeved and just laying in the box.Per follow up on 04mar2021 the patient developed a urinary tract infection since using the catheter from the foley tray but was uncertain whether it was caused by the catheter.The patient was treated with prescribed antibiotics.Also stated there was no sample port on the bag or tubing even though it was mentioned that it contains a sample port.Also the customer provided quantity as 4.
 
Manufacturer Narrative
The reported event was confirmed however the cause was unknown.The reported failure was able to be reproduced.The product was used for urological care.Evaluation found no polysleeve for the returned catheter.However, the exact cause of how and when the problem occurred could not be determined.A potential root cause for this failure could be due to mechanical failure, operator error, user related (eg: mishandling of device).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: "warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." the actual/suspected device was evaluated.
 
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Brand Name
BARDIA FOLEY CATHETER SILICONE COATED
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11377983
MDR Text Key233492073
Report Number1018233-2021-00782
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number123516A
Device Lot NumberMYDY0952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Date Manufacturer Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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