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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN FILIFORM SPIRAL TIP 12.5" (31.75CM) 5 FR., STERILE

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C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN FILIFORM SPIRAL TIP 12.5" (31.75CM) 5 FR., STERILE Back to Search Results
Catalog Number 022105
Device Problems Flaked (1246); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2019
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 with manipulation during a cystoscopy, the end of the catheter appeared to be flaking off into the bladder. The ureter was still catheterized by dr. (b)(6). No injury noted.
 
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Brand NameBARD WOVEN FILIFORM SPIRAL TIP 12.5" (31.75CM) 5 FR., STERILE
Type of DeviceBARD WOVEN FILIFORM SPIRAL TIP
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8386671
MDR Text Key137944683
Report Number1018233-2019-01133
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
0 Patients were 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
Device Catalogue Number022105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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