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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN TEMPERATURE SENSING FOLEY PROBE
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN TEMPERATURE SENSING FOLEY PROBE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 customer has had issues with the foley probe giving inaccurate temps while in use with the gaymar blanket.The complainant reported that the blanket was set for 33c, but the foley was reading 34c.
 
Event Description
It was reported that the customer has had issues with the foley probe giving inaccurate temps while in use with the gaymar blanket.The complainant reported that the blanket was set for 33c, but the foley was reading 34c.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿sensor wire breaks thermistor cracks or breaks¿ with a potential root cause of ¿sensor wire too weak or thermistor chip too weak¿.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.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.
 
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Brand Name
UNKNOWN TEMPERATURE SENSING FOLEY PROBE
Type of Device
TEMPERATURE SENSING FOLEY PROBE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9512326
MDR Text Key177974270
Report Number1018233-2019-08199
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received01/03/2020
Supplement Dates FDA Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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