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

Model Number	897418
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be 'damage package hole/tears (film/tyvek/paper)¿ with a potential root cause of 'sharp edges'.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water, do not exceed recommended capacities.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.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.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.".
Event or Problem Description
It was reported that one of the previous items from this lot experienced air leakage.As a result, the facility would not use any product from this lot number.Customer's inventory (7 cases) with this lot number was returned and replaced through customer service for the product with a different lot number.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY TRAY - CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8944662
• Report Number: 1018233-2019-05205
• Device Sequence Number: 16666067
• Product Code: EZL
• UDI-Device Identifier: 00801741020308
• UDI-Public: (01)00801741020308
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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
• Report Date (Section B): 08/29/2019

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 Expiration Date: 07/31/2021
• Device Model Number: 897418
• Device Catalogue Number: 165818
• Device Lot Number: NGCX4241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1