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

Catalog Number 129414M

Device Problem Difficult to Remove (1528)

Patient Problems Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the next day after op, the patient complained of discomfort, when they tried to remove the foley catheter again, they felt some resistance, but they were able to remove it.At that time, a small amount of bleeding was observed from the urethral opening.When the catheter was removed, a portion of the balloon was observed to be deformed, and it was assumed that this deformation was related to the feeling of resistance during removal.It was confirmed that the syringe used to remove water other company product.No medical intervention was reported.

Event Description

It was reported that the next day after op, the patient complained of discomfort, when they tried to remove the foley catheter again, they felt some resistance, but they were able to remove it.At that time, a small amount of bleeding was observed from the urethral opening.When the catheter was removed, a portion of the balloon was observed to be deformed, and it was assumed that this deformation was related to the feeling of resistance during removal.It was confirmed that the syringe used to remove water other company product.No medical intervention was reported.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.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 ·patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) 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.] (5) 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.] 2.Applicable patients with known allergy to silver coated catheter [directions for use] 1.Method of use 1) cleanse the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered.[precautions] 1.Precautions for use (exercise caution when using the device in the following patients) 1) exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important precautions 1) when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.2) when any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.3) when it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section ¿troubleshooting¿.3.Malfunction and adverse events 1) malfunction catheter kinking, damage, rupture difficulty or failure to remove the device occlusion of catheter inner lumens encrustation accidental removal of the device due to leakage of sterile water or balloon rupture device damage due to inappropriate use failure to measure temperature improper temperature indication 2) adverse events urinary-tract infection hemorrhage, hematuria allergy reaction to the device calculus formation edema pain discomfort injury of bladder or urethral urethritis, urinary incontinence retained balloon fragments [storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box." correction: d,g.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19170004
• MDR Text Key: 341711561
• Report Number: 1018233-2024-02237
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910318
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 129414M
• Device Lot Number: MYHW3623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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