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

Model Number	0168L18
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the foley catheter fell out of the patient during a procedure with the balloon fully deflated.The complainant reported that blood was found at the tip of the meatus allegedly due to the catheter falling out.No medical intervention was required and no missing piece were reported.
Event or Problem Description
It was reported that the foley catheter fell out of the patient during a procedure with the balloon fully deflated.The complainant reported that blood was found at the tip of the meatus allegedly due to the catheter falling out.No medical intervention was required and no missing piece were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿·when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.[fragment of the balloon or segment of catheter may remain in the bladder.] ·do not pull the catheter hard.[the catheter including a balloon may be damaged or the bladder/urethral mucous membrane may be injured.]¿.·since it may be difficult to remove catheter even after balloon deflation in some cases, the catheter should be removed under the physician¿s instructions by reference to the section ¿troubleshooting¿.·when deflating balloon, allow balloon to deflate on its own; do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the balloon cannot be removed.] ·when inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and make sure to keep the stylet on place inside the catheter during insertion [the stylet may exit the side hole to damage the urethral mucosa.] - applicable patients ·use with great care for patients with disturbance of consciousness, etc.[when patient removes catheter unconsciously, the mucosa of the bladder and urethra may be damaged, balloon may be ruptured, catheter may be broken, and catheter fragments may be left behind in the bladder.]".

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8305051
• Report Number: 1018233-2019-00597
• Device Sequence Number: 59561
• Product Code: EZC
• UDI-Device Identifier: 00801741017834
• UDI-Public: (01)00801741017834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0168L18
• Device Catalogue Number: 0168L18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1