MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH; FOLEY CATHETER (LATEX)

Catalog Number 0165L14

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem Confusion/ Disorientation (2553)

Event Date 01/29/2017

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 the catheter broke.The catheter was inserted into the patient in the emergency room.The patient was allegedly experiencing delirium, and it was reported that the patient pulled on the catheter.The catheter was torn off and the proximal end (tip) of the catheter remained inside of the patient.Two days later, the remaining piece was retrieved with a cystoscope, and no injury was reported.

Manufacturer Narrative

Received only catheter cut into 2 pieces.The reported event was confirmed as user related.The sample was evaluated and it was observed that the catheter was broke at the catheter shaft.The surface was normal in appearance with the presence of typical jagged tearing which results from breakage of the catheter.The tearing looked like the shaft was pulled with external forced that could have caused the catheter break.The unit was inspected for the presence of oxidation, acid cuts, abrasions, external cuts or tears that could cause the shaft to break.None of the conditions were evident on the sample.The breakage did not occur as a result of any manufacturing process related cause.The dimensional evaluation results were as follows: 1st piece (catheter shaft) - 36 cm long 2nd piece - 6.5cm long from tip the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state 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 the catheter broke.The catheter was inserted into the patient in the emergency room.The patient was allegedly experiencing delirium, and it was reported that the patient pulled on the catheter.The catheter was torn off and the proximal end (tip) of the catheter remained inside of the patient.Two days later, the remaining piece was retrieved with a cystoscope, and no injury was reported.

• Brand Name: BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6374927
• MDR Text Key: 68972859
• Report Number: 1018233-2017-00835
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 0165L14
• Device Lot Number: 6GE9009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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