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

Model Number 1758SI16

Device Problems Inaccurate Flow Rate (1249); Defective Component (2292)

Patient Problems Pain (1994); Urinary Retention (2119)

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 the catheters did not drain properly.The complainant reported that the patient complained of pain or ¿full feeling¿ and they saw that there wasn't any urine output.The complainant noted that the patient would then be repositioned or the staff would have the patient get up to walk and the bag fills with urine.The complainant reportedly talked to the staff about the vent on the bags and doing an accordion motion prior to inserting the foleys, but the staff reportedly mentioned that the bags are sealed so tight that the vent did not seem to work like it should.No medical intervention was reported.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿collapsed lumen.Blocked lumen¿.A potential root cause for this failure could be "biological deposits or physiological obstruction (¿ patient position ¿ kinked catheter)".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: "visually inspect the product for any imperfections or surface deterioration prior to use." 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.

Event Description

It was reported that the catheters did not drain properly.The complainant reported that the patient complained of pain or ¿full feeling¿ and they saw that there wasn't any urine output.The complainant noted that the patient would then be repositioned or the staff would have the patient get up to walk and the bag fills with urine.The complainant reportedly talked to the staff about the vent on the bags and doing an accordion motion prior to inserting the foleys, but the staff reportedly mentioned that the bags were sealed so tight that the vent did not seem to work like it should.No medical intervention was reported.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8753020
• MDR Text Key: 149947596
• Report Number: 1018233-2019-03519
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGCZ3986
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1