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 Problems Inaccurate Flow Rate (1249); No Flow (2991)
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 catheter had to be manipulated in order to drain urine.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this all silicone catheter is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the all silicone catheter ifus are found to be adequate based on past reviews.The device was not returned.
 
Event Description
It was reported that the catheter had to be manipulated in order to drain urine.
 
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 Key8024888
MDR Text Key125765381
Report Number1018233-2018-05072
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
Report Date 11/30/2018
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 10/08/2018
Initial Date FDA Received10/31/2018
Supplement Dates Manufacturer Received11/06/2018
Supplement Dates FDA Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-