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

Model Number 0168L14

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the foley catheter was broken because the patient pulled it out by oneself on the 4th day of use.The tip of the catheter was remained inside the patient and it was removed by the urologist doctor.Per follow up via etsuko on 13oct2020, the tip remained inside the patient and was removed using a cystoscope.There was no impact to patient.

Manufacturer Narrative

The reported event was confirmed as use related.1 sample was confirmed to exhibit the reported failure.It was unknown if the product had met specifications as it was returned in poor condition.The failure was caused by the misuse of the product.A potential root cause for this failure could be user did not follow procedure.An amber 2 way foley catheter was returned.The catheter was found to have a bandage wrapped just above the bifurcation.The entire tip including the eyelet is broken off.Both pieces were returned.Per event reported the catheter broke when the patient attempted to remove it by them self.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use: (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients: (1) patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered." h11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the foley catheter was broken because the patient pulled it out by oneself on the 4th day of use.The tip of the catheter was remained inside the patient and it was removed by the urologist doctor.Per follow up on (b)(6) 2020, the tip remained inside the patient and was removed using a cystoscope.There was no impact to patient.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER COUDE TIP
• Type of Device: LUBRICATH FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10752126
• MDR Text Key: 213684979
• Report Number: 1018233-2020-20535
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017810
• UDI-Public: (01)00801741017810
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0168L14
• Device Catalogue Number: 0168L14
• Device Lot Number: NGENX776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2020
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention