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

Model Number	176816
Medical Device Problem Code	Material Invagination (1336)
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.
Event or Problem Description
It was reported that the catheter deflated prematurely and caused the balloon to mushroom.As a result the catheter was difficult to remove.No medical intervention was reported.
Event or Problem Description
It was reported that the catheter deflated prematurely and caused the balloon to mushroom.As a result the catheter was difficult to remove.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley covered in biological tissue and bodily fluids.It was noted that on the catheter, there was cuffing on the catheter balloon.Per specification, the balloon should not cuff after deflation.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be low cure temperature.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: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Unless package is opened or damaged.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 tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.Bard, bardex and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.U.S.Patent number 5,179,174 and patent pending.To deflate catheter balloon: gently insert a luer slip tip 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.".

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: ALL-SILICONE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8612574
• Report Number: 1018233-2019-02573
• Device Sequence Number: 3019940
• Product Code: EZL
• UDI-Device Identifier: 00801741034213
• UDI-Public: (01)00801741034213
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K984084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: Lay User/Patient
• Device Expiration Date: 03/12/2023
• Device Model Number: 176816
• Device Catalogue Number: 176816
• Device Lot Number: NGCP1350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1