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

Model Number	0166SI20
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that the catheter leaked.The location of the leak was unknown.
Event or Problem Description
It was reported that the catheter leaked.The location of the leak was unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "[warning] method for use: 1.Since it may be difficult to remove catheter even after balloon deflation in some cases, the catheter should be removed under the physician's instruction by reference to the section" troubleshooting".2.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.3.When catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, damage, etc.Before inserting a new catheter.Fragments of the balloon or segment of catheter may remain in the bladder.4.When inserting catheter with a stylet, confirmed that the stylet has reached the tip of the catheter, and then insert without pulling them back.Otherwise, the stylet may exit the side hole to damage the urethral mucosa.[caution] - 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." section a through f - the information provided by bard 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 bard.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: BARDEX IC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7473521
• Report Number: 1018233-2018-01384
• Device Sequence Number: 334029
• Product Code: MJC
• UDI-Device Identifier: 00801741016868
• UDI-Public: (01)00801741016868
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 0166SI20
• Device Catalogue Number: 0166SI20
• Device Lot Number: NGBY0483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1