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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Model Number 1758SI16
Device Problem Difficult to Remove (1528)
Patient Problem Pain (1994)
Event Date 02/22/2022
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 over the past couple of weeks, there have been multiple instances of the foley catheter balloon deflating.Patients also have been complaining of pain more frequently when they have the foley catheter in place.It was reported that the nurse had a patient who had really bad pain associated with the catheter and when the nurse went to remove it, there was only 1cc that came out of the balloon when the nurse deflated it.It was also reported that other nurses also had a couple of instances of the similar issue as well.No medical intervention was reported.
 
Event Description
It was reported that over the past couple of weeks, there have been multiple instances of the foley catheter balloon deflating.Patients also have been complaining of pain more frequently when they have the foley catheter in place.It was reported that the nurse had a patient who had really bad pain associated with the catheter and when the nurse went to remove it, there was only 1cc that came out of the balloon when the nurse deflated it.It was also reported that other nurses also had a couple of instances of the similar issue as well.No medical intervention was reported.Per follow up via email on 15apr2022, it was reported that a nurse removed a foley catheter and it only had 7-8 ml in it.The instances that happened prior had balloons that only had 1-2 ml upon removal, so customer unsure if this was an education issue with whoever inserted it, or if it was the same issue they were having previously.However, the nurse did save the foley in case anyone wanted to look at it.Per additional information received via 01jun2022, stated that they have seen a cluster of foley catheters that only had 1-2 ml left in balloon when deflated a couple of months ago.That foley catheter had 7-8 ml when deflated.
 
Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing silicone foley catheter.Visual inspection of the sample noted no obvious visual observations.No root cause could be found because the reported event was unconfirmed.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.
 
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Brand Name
BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
Type of Device
TEMPERATURE SENSING FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13827463
MDR Text Key287538239
Report Number1018233-2022-01421
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741025228
UDI-Public(01)00801741025228
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1758SI16
Device Catalogue Number119216M
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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