MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; FOLEY CATHETER (LATEX)

Catalog Number 0119L16

Device Problems Break (1069); Component Falling (1105); Torn Material (3024)

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

Event Date 02/13/2017

Event Type  malfunction  

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 catheter breakage was found.The catheter was inserted into the patient at a ward.The following day, it was found that the catheter was torn and had fallen out of the patient.There were no missing pieces found.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection observed the catheter was broken at the catheter shaft.Evaluation concluded that the break most likely resulted from the patient's effort to prematurely remove the catheter, as the breakage did not occur as a result of any manufacturing process related cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿contraindications method for use: do not reuse.Do not resterilize.Be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" (b)(4).

Event Description

It was reported that catheter breakage was found.The catheter was inserted into the patient at a ward.The following day, it was found that the catheter was torn and had fallen out of the patient.There were no missing pieces found.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection observed the catheter was broken at the catheter shaft.Evaluation concluded that the break most likely resulted from the patient's effort to prematurely remove the catheter, as the breakage did not occur as a result of any manufacturing process related cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" (b)(4).

Event Description

It was reported that catheter breakage was found.The catheter was inserted into the patient at a ward.The following day, it was found that the catheter was torn and had fallen out of the patient.There were no missing pieces found.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• MDR Report Key: 6398125
• MDR Text Key: 70056898
• Report Number: 1018233-2017-01040
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 0119L16
• Device Lot Number: 6FL7022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1