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 ALL SILICONE CATHETER
  • 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 ALL SILICONE CATHETER Back to Search Results
Device Problem Disconnection (1171)
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.The device was not returned.
 
Event Description
It was reported that the irrigating saline connection of the latex free 3-way catheter became disconnected prior to the patient being scanned.There was no reported significant delays to the procedure or patient injury.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.A labeling review could not be completed since the product catalog # was not provided, and there is not enough information to determine the labeling to be inadequate.
 
Event Description
It was reported that the irrigating saline connection of the silicone catheter became disconnected prior to the patient being scanned.There was no reported significant delays to the procedure or patient injury.
 
Event Description
It was reported that the irrigating saline connection of the latex free 3-way catheter became disconnected prior to the patient being scanned.There was no reported significant delays to the procedure or patient injury.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALL SILICONE CATHETER
Type of Device
SILICONE CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8386670
MDR Text Key137968787
Report Number1018233-2019-01129
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,user facility
Type of Report Initial,Followup,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-