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

Catalog Number 0165L14

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2023

Event Type  Injury  

Event Description

It was reported that the catheter was broken.The head nurse of the ward stated that the patient pulled the catheter and that was the first time the catheter broke.Since the event was a patient deprived phenomenon, the sales representative explained the handling precautions and asked for understanding but the customer requested to recover the sample and investigate.Per additional information via email from ibc on (b)(6) 2023, it was stated that the a broken parts had left inside the patient's body.However, after the foley catheter is torn out, the remaining portion of the broken catheter in the bladder was removed by a urologist using a cystoscope.The bladder and urethra were judged to be undamaged since there was no hematuria, and the patient's condition did not deteriorate.

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.

Manufacturer Narrative

The reported event was confirmed ¿ user related.The reported failure was able to be reproduced.The product was used for urological care.The product had caused the reported failure.Evaluated the sample and observed the tip of the returned catheter was missing.As per reported event, the catheter tip had broken when it was pulled out by the user.Hence, the reported event is confirmed as user related.The potential root cause for this failure mode could be user related since the patient had pulled the catheter.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore no additional action required at this time.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.] [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 (1) do not use in patients who are or have been allergic to natural rubber latex [intended use & effect- efficacy] the device combines an indwelling bladder catheter and a urinary drainage bag that are used for urinary drainage and bladder irrigation.[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 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: b,d,f,h 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.

Event Description

It was reported that the catheter was broken.The head nurse of the ward stated that the patient pulled the catheter and that was the first time the catheter broke.Since the event was a patient deprived phenomenon, the sales representative explained the handling precautions and asked for understanding but the customer requested to recover the sample and investigate.Per additional information via email from ibc on (b)(6)2023, it was stated that the a broken parts had left inside the patient's body.However, after the foley catheter is torn out, the remaining portion of the broken catheter in the bladder was removed by a urologist using a cystoscope.The bladder and urethra were judged to be undamaged since there was no hematuria, and the patient's condition did not deteriorate.

• Brand Name: BARDEX® LUBRICATH® 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: 17216191
• MDR Text Key: 318025652
• Report Number: 1018233-2023-04758
• 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: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L14
• Device Lot Number: MYGX1298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2022
• 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