Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS; UNKNOWN FOLEY TRAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS; UNKNOWN FOLEY TRAY Back to Search Results
Device Problems Biocompatibility (2886); Contamination /Decontamination Problem (2895)
Patient Problems Pain (1994); Toxicity (2333); Injury (2348)
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 the patient had experienced malignant pleural mesothelioma from asbestos exposure from the gloves and powder of a foley catheter kit.The patient was claimed pain, suffering and mental anguish.
 
Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿inadvertent contamination/mechanical or chemical response¿.The device was used for the treatment, though it was unknown whether the device was related to the reported event or met specifications.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore, bard was 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.
 
Event Description
It was reported that the patient had experienced malignant pleural mesothelioma from asbestos exposure from the gloves and powder of a foley catheter kit.The patient was claimed pain, suffering and mental anguish.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FOLEY TRAYS
Type of Device
UNKNOWN FOLEY TRAY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10246684
MDR Text Key198071921
Report Number1018233-2020-04408
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/15/2020
Initial Date FDA Received07/08/2020
Supplement Dates Manufacturer Received08/16/2020
Supplement Dates FDA Received09/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
-
-