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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. BD SILICONE FOLEY.; CATHETER, RETENTION TYPE, BALLOON.
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C. R. BARD, INC. BD SILICONE FOLEY.; CATHETER, RETENTION TYPE, BALLOON. Back to Search Results
Catalog Number 165812
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2022
Event Type  Injury  
Event Description
The 2 incidents with bard silicone foley, size 10fr and 12fr.Placed intraoperatively.The balloon of 10 fr deflated and foley dislodged from patient requiring another placement undersedation, replaced with 12fr - which also dislodged, and patient was brought back for another placement under sedation.The attending physician examined both products once removed from the patient and found there were very small holes in the silicone balloon causing a slow leakage of fluid from the balloon.Ref# 165812; lot# ngen4736 company representative also made aware of issues: (b)(6).Fda safety report id # (b)(4).
 
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Brand Name
BD SILICONE FOLEY.
Type of Device
CATHETER, RETENTION TYPE, BALLOON.
Manufacturer (Section D)
C. R. BARD, INC.
MDR Report Key13770649
MDR Text Key287391587
Report NumberMW5108160
Device Sequence Number2
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 03/11/2022
2 Devices were Involved in the Event: 1   2  
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
Device Catalogue Number165812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Hospitalization;
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