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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER Back to Search Results
Device Problems Burst Container or Vessel (1074); Crack (1135); Material Rupture (1546); 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 Date 05/28/2020
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 underwent radical cystectomy and replacement of bladder with brick ileum under laparoscope under general anesthesia at 10:00 on (b)(6).At 18:00, the patient was returned to ward safely, with dressing on incision dry visually.Gastrointestinal decompression tubing was attached with a negative pressure bag, with insertion depth of 60 cm.No fluid was aspirated for the being.A drainage tube passing through the urethra was attached with a urinary bag and a pelvic cavity drainage tube was attached with a urinary bag.New bladder drainage tube was in place and connected to an ostomy bag to drain light red urine, the drainage passing through the urethra fell off, which was a bard fr22 triple-lumen urethral catheter indwelled intraoperatively.There was a crack in the balloon which caused balloon rupture and the catheter was detached.No residues were left in the body of this patient.No discomfort was reported.Suspended using the drainage tube on the order of doctor and observed the dressing status on the incision, and strengthened inspection.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.However, the potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator error.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the foley catheter ifus were 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.
 
Event Description
It was reported that the patient underwent radical cystectomy and replacement of bladder with brick ileum under laparoscope under general anesthesia at 10:00 on (b)(6).At 18:00, the patient was returned to ward safely, with dressing on incision dry visually.Gastrointestinal decompression tubing was attached with a negative pressure bag, with insertion depth of 60 cm.No fluid was aspirated for the being.A drainage tube passing through the urethra was attached with a urinary bag and a pelvic cavity drainage tube was attached with a urinary bag.New bladder drainage tube was in place and connected to an ostomy bag to drain light red urine, the drainage passing through the urethra fell off, which was a bard fr22 triple-lumen urethral catheter indwelled intraoperatively.There was a crack in the balloon which caused balloon rupture and the catheter was detached.No residues were left in the body of this patient.No discomfort was reported.Suspended using the drainage tube on the order of doctor and observed the dressing status on the incision, and strengthened inspection.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10195630
MDR Text Key196916380
Report Number1018233-2020-04102
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
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 Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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