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

Model Number 73022L

Device Problems Inability to Irrigate (1337); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that there was no flow from the 3-way silicone foley catheter, and the physician was unable to irrigate the catheter using a syringe.Reportedly, it was the second time the incident had occurred.

Event Description

It was reported that there was no flow from the 3-way silicone foley catheter, and the physician was unable to irrigate the catheter using a syringe.Reportedly, it was the second time the incident had occurred.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿reduced or no irrigation flow¿ with a potential root cause of ¿kinked/pinched irrigation lumen or no irrigation eye¿.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: ¿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.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, 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." 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: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: BARD LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9750772
• MDR Text Key: 184297152
• Report Number: 1018233-2020-01315
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034329
• UDI-Public: (01)00801741034329
• Combination Product (y/n): N
• PMA/PMN Number: K070558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 73022L
• Device Catalogue Number: 73022L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1