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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETERS; FOLEY CATHETER (LATEX FREE)
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C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETERS; FOLEY CATHETER (LATEX FREE) Back to Search Results
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
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 patient faced three separate occasions with the foley catheter pulled out.On inspection of the balloons of the 14 fr latex free catheter the balloons were ruptured open.After consultation with urologist the patient recommended to use 14 fr silicone foley which was well inserted.
 
Event Description
It was reported that the patient faced three separate occasions with the foley catheter pulled out.On inspection of the balloons of the 14 fr latex free catheter the balloons were ruptured open.After consultation with urologist the patient recommended to use 14 fr silicone foley which was well inserted.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "high modulus latex".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore,labeling review could not be performed.Although the product family is unknown, the lubri-sil foley catheter product ifus are found to be adequate based on past reviews.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.
 
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Brand Name
LUBRI-SIL FOLEY CATHETERS
Type of Device
FOLEY CATHETER (LATEX FREE)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10145547
MDR Text Key195231599
Report Number1018233-2020-03747
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 company representative,other
Type of Report Initial,Followup
Report Date 07/06/2020
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 05/20/2020
Initial Date FDA Received06/11/2020
Supplement Dates Manufacturer Received06/18/2020
Supplement Dates FDA Received07/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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