MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARDEX 5CC RED LATEX LUBRICATH COUDE TIP; COUDE CATHETER

Catalog Number 0102L20

Device Problem Torn Material (3024)

Patient Problems Staphylococcus Aureus (2058); Urinary Tract Infection (2120); Confusion/ Disorientation (2553); Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2015

Event Type  Injury  

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

It was reported that a confused patient pulled out his foley catheter, but allegedly the product tore "at mid urethra" leaving a large section of the catheter in the patient.The foley was inserted on (b)(6) 2015 by a urologist.The removal of the retained piece was done on (b)(6) 2015 by cystoscopy.Another catheter was placed by a urologist.The patient was fine after removal and discharged on (b)(6) 2015.The patient was readmitted on (b)(6) 2015 with a diagnosis of a urinary tract infection and then was discharged on (b)(6) 2015.During the readmission the infectious disease physician noted: "(b)(6) bacteremia-likely due to trauma related to broken foley catheter." the facility alleges that the foley catheter was "cut" it appears the cut goes at an angle on the foley catheter.

Manufacturer Narrative

Received photos of the sample.Inspected the photo of the partial sample and did not find anything that would contribute to the reported event.The lot number is unknown therefore the device history record could not be reviewed.The complaint was inconclusive due to the poor sample condition of the photo received.The instructions for use state the following: "caution: this product contains natural rubber latex which may cause allergic reactions." (b)(4).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.Device not returned.

• Brand Name: BARDEX 5CC RED LATEX LUBRICATH COUDE TIP
• Type of Device: COUDE 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: 5223601
• MDR Text Key: 31196051
• Report Number: 1018233-2015-00469
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0102L20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 129