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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN LATEX TEMP-SENSING CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN LATEX TEMP-SENSING CATHETER Back to Search Results
Device Problems No Apparent Adverse Event (3189); Missing Information (4053)
Patient Problems Fever (1858); Local Reaction (2035); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/04/2021
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 latex foley catheter was inserted on a known latex-allergic patient because the clinician could not see the labeling due to the packaging of the foley kit.It was happened in intensive care unit and patient experienced fever and swelling.Medication intervention was required.Another issue was lack of a latex label which lead to an allergic reaction with the foley catheter.
 
Manufacturer Narrative
The reported event was confirmed as customer preference complaint.Visual evaluation of the photo sample noted one opened unused latex foley tray.Visual inspection of the first photo noted that the latex label was clearly visible.The second and third pictures show that the packaging completely covers the warning label.However, as this part that was covered needed to be removed to open the tray, the user should still be able to see the label.As a result, this complaint would be treated as a customer preference complaint.The device history record review and labeling review was not performed as this was a customer preference complaint.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 actual/suspected device was inspected.
 
Event Description
It was reported that the latex foley catheter was inserted on a known latex-allergic patient because the clinician could not see the labeling due to the packaging of the foley kit.It was happened in intensive care unit and patient experienced fever and swelling.Medication intervention was required.Another issue was lack of a latex label which lead to an allergic reaction with the foley catheter.
 
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Brand Name
UNKNOWN LATEX TEMP-SENSING CATHETER
Type of Device
UNKNOWN LATEX TEMP-SENSING CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11579588
MDR Text Key243413075
Report Number1018233-2021-01662
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 health professional,other
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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