MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARDEX 5CC LUBRICATH 2-WAY LATEX FOLEY CATHETER

Catalog Number 0168L16

Device Problems Deflation Problem (1149); No Device Output (1435); Material Rupture (1546)

Patient Problem Death (1802)

Event Date 05/06/2015

Event Type  Death  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

Bard medical division field assurance received notification on 9/10/2015 via fda medwatch report that a patient death had occurred.A hospital representative at (b)(6) reported that a bardex foley catheter was allegedly inserted to a (b)(6) male patient and initially drained 25ml of urine, but then stopped draining.A bladder scan was performed and allegedly showed the patient had 600ml of urine in his bladder.The nurse attempted to deflate the balloon, but was unsuccessful.A urologist was consulted who allegedly instilled 3ml of mineral oil into the balloon.After several minutes had elapsed, the balloon ruptured and the catheter came out.The urologist planned to perform a cystoscopy after the patient was stabilized to determine if any pieces of the balloon remained in the patient, but the patient expired before the procedure could be performed.Bard medical division field assurance reached out to the facility on 09/11/2015 to gather additional information.According to the facility, the catheter was placed on (b)(6) 2015 due to urinary obstruction (previous prostatectomy) and was deflated/removed same day.An unknown amount of saline was used to inflate the tube and it is unknown what type of lubricant was used on the catheter.There was not any irrigation being performed.The catheter was not being used for hemostasis or bladder drainage and there was no traction applied or sutures used to anchor the catheter.Another catheter was placed and no additional intervention was performed.It is unknown if there were any missing pieces from the balloon.The urologist had planned on doing a cystoscopy after the patient stabilized from his underlying cardiac condition; however, the patient expired on (b)(6) 2015 prior to the procedure being performed due to sepsis.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.The information provided by bard 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 bard.

• Brand Name: BARDEX 5CC LUBRICATH 2-WAY LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• Manufacturer (Section G): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5128536
• MDR Text Key: 27505023
• Report Number: 1018233-2015-00373
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0168L16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 103