MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 BARD 5CC ECONOMY LUBRICATH LATEX FOLEY CATHETER WITH 5CC BALLOON

Catalog Number 365714

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2016

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 foley catheter was inserted into the patient.The urine was able to drain via the catheter then allegedly stopped draining.The catheter was noted to be coming out of the patient.An attempt to remove fluid from the balloon was made, but no fluid returned.The foley came out with the balloon not inflated.Upon inspection, a small tear was allegedly noted to the balloon that was not noted prior to insertion.There were no pieces reported missing.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "visually inspect the product for any imperfections or surface deterioration prior to use" and "do not exceed recommended capacities".(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.The device was not returned.

Event Description

It was reported that the foley catheter was inserted into the patient.The urine was able to drain via the catheter then allegedly stopped draining.The catheter was noted to be coming out of the patient.An attempt to remove fluid from the balloon was made, but no fluid returned.The foley came out with the balloon not inflated.Upon inspection, a small tear was allegedly noted to the balloon that was not noted prior to insertion.There were no pieces reported missing.

• Brand Name: BARD 5CC ECONOMY LUBRICATH LATEX FOLEY CATHETER WITH 5CC BALLOON
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer (Section G): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6106175
• MDR Text Key: 60551659
• Report Number: 1018233-2016-01636
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 365714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• 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