MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 16FR FOLEY CATHETER; VERTUS

Model Number	AF42216
Medical Device Problem Code	Difficult to Remove (1528)
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 water leaked from the catheter when the user injected water during a pretest.
Event or Problem Description
It was reported that the catheter had issues with deflation.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿no flow¿ with a potential root cause of "lumen collapses under the pressure of the balloon".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: ¿caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Contraindications: none known.Warnings: ¿ do not use ointments having a petrolatum base.They will damage the catheter and may cause the balloon to burst.¿ this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Cautions/precautions: ¿ maximum indwelling time should be less than 30 days.¿ urethral strictures, false passages, prostatic enlargement, and post surgical bladder neck contractures can make urethral catheterization difficult and may require the services of a urologist.¿ do not aspirate urine through drainage funnel.¿ do not use if package is damaged.¿ storage: store catheters at room temperature away from direct exposure to light, preferably in original box.¿ consult accompanying documents.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Adverse reactions: as with any foley catheter, there is potential for adverse reactions that may occur as part of use of this device including, but not limited to: ¿ urinary tract infection ¿ infection ¿ balloon rupture ¿ difficulty deflating the balloon ¿ difficulty removing the catheter ¿ blockage" h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: 16FR FOLEY CATHETER
• Common Device Name: VERTUS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9386696
• Report Number: 1018233-2019-07617
• Device Sequence Number: 2654697
• Product Code: EZL
• UDI-Device Identifier: 00801741099090
• UDI-Public: (01)00801741099090
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: AF42216
• Device Catalogue Number: 0165B16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1