MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

Model Number 119314

Device Problem Partial Blockage (1065)

Patient Problem Hematuria (2558)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

It was reported that the urine outflow of the foley catheter was poor, so this catheter was discontinued.The patient experienced a little hematuria after the foley catheter was indwelled.No medical intervention was reported.As per follow up information received on 24nov2021, the urine flow was slower than usual and there was no blockage in the catheter.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing silicone foley catheter with cut portion of inlet tubing.Visual inspection of the sample noted no obvious visible observations.A potential root cause for this failure mode could be ¿drainage eye too small¿.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: method for use do not inflate the balloon in the urethra.The urethra may be injured.Do not pull the catheter hard.The bladder/urethra may be injured.Applicable patients: patients with delirium who might pull out catheter when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.Contraindications: method for use: do not reuse.Do not resterilize.This device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.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.Applicable patients: patients with known allergy to silver coated catheter.The actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14594342
• MDR Text Key: 293336705
• Report Number: 1018233-2022-04363
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGFP4119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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): Other