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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Catalog Number 129414M
Device Problems Material Perforation (2205); Patient-Device Incompatibility (2682); No Flow (2991)
Patient Problems Internal Organ Perforation (1987); No Code Available (3191)
Event Date 10/20/2018
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 no urine flowed from the catheter therefore a ct examination was conducted and found a perforation in the bladder, so catheter was removed.A new catheter was placed in the patient on (b)(6) 2018 and observation of the patient continued.The nurse stated that when the catheter was inserted 5 cm, there was urine flow and then it was inserted another 2cm.The nurse stated that when catheterizing a patient, they insert the foley (regardless of gender) past the balloon to the bifurcation.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" correction: event.
 
Event Description
It was reported that a balloon catheter was placed in the patient with cerebral disorder, on (b)(6)2018.After the catheter was placed and urine flow was confirmed, the catheter was inserted another 2cm.On (b)(6)2018 , there was no urine flow and a ct scan revealed that the catheter perforated the bladder.The catheter was removed and a new catheter was placed.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" correction: outcomes attributed to adverse event, event.
 
Event Description
It was reported that a balloon catheter was placed in the patient with cerebral disorder, on 1(b)(6)2018.After the catheter was placed and urine flow was confirmed, the catheter was inserted another 2cm.On (b)(6)2018, there was no urine flow and a ct scan revealed that the catheter perforated the bladder.The catheter was removed and a new catheter was placed.It was later reported on (b)(6)2019 from the pharmaceuticals and medical devices agency (pmda) report that according to the facility, the bladder was torn when the balloon was inflated in the diverticulum of the bladder.The bladder injury was resolved without any intervention.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" correction: outcomes attributed to adverse event.
 
Event Description
It was reported that a balloon catheter was placed in the patient with cerebral disorder, on (b)(6)2018.After the catheter was placed and urine flow was confirmed, the catheter was inserted another 2cm.On (b)(6)2018 , there was no urine flow and a ct scan revealed that the catheter perforated the bladder.The catheter was removed and a new catheter was placed.It was later reported on (b)(6)2019 from the pharmaceuticals and medical devices agency (pmda) report that according to the facility, the bladder was torn when the balloon was inflated in the diverticulum of the bladder.The bladder injury was resolved without any intervention.
 
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Brand Name
BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
Type of Device
TEMPERATURE SENSING FOLEY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8095704
MDR Text Key128095750
Report Number1018233-2018-05590
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number129414M
Was Device Available for Evaluation? No
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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