MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

Model Number	1758SI24
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Hematuria (2558)
Type of Reportable Event	Serious Injury
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 foley catheter was blocked with sediment; and the patient could not pass urine.Allegedly the patient experienced pain and developed a urinary tract infection, and was treated with levaquin antibiotics.The complainant noted that the patient's daughter flushed the foley catheter daily and noticed blood in the patient's urine.
Event or Problem Description
It was reported that the foley catheter was blocked with sediment; and the patient could not pass urine.Allegedly the patient experienced pain and developed a urinary tract infection, and was treated with levaquin antibiotics.The complainant noted that the patient's daughter flushed the foley catheter daily and noticed blood in the patient's urine.
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: ¿lubri-sil® i.C.Anti-microbial all-silicone foley catheter with bard hydrogel and bacti-guard silver alloy coating infection control all-silicone foley catheter 100% latex-free warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Caution: do not aspirate the urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Catheters should be replaced in accordance with the cdc guideline ¿guideline for prevention of catheter-associated urinary tract infection¿.At the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter-related adverse effect, the catheter should be replaced.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 5 cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities." correction: concomitant medical products,device evaluated by mfr, and mfr site.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7616387
• Report Number: 1018233-2018-02339
• Device Sequence Number: 16499326
• Product Code: EZL
• UDI-Device Identifier: 00801741025266
• UDI-Public: (01)00801741025266
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 1758SI24
• Device Catalogue Number: 1758SI24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention