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

Model Number 119216M

Device Problems Deflation Problem (1149); Inaccurate Flow Rate (1249); Fluid/Blood Leak (1250)

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 the balloon leaked sterile water within a few hours of insertion and caused premature deflation.The catheter either fell out or did not drain properly.The patient went through multiple catheter replacements.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be ¿occlusion where funnel meets shaft¿ with a potential root cause of ¿design narrows at junction to lumen¿.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: "maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.Maintain unobstructed urine flow and keep the catheter and collection tube from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly(e.G., prior to transport) use a separate, clean collection container for each patient." 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.

Event Description

It was reported that the balloon leaked sterile water within a few hours of insertion and caused premature deflation.The catheter either fell out or did not drain properly.The patient went through multiple catheter replacements.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8525389
• MDR Text Key: 142344512
• Report Number: 1018233-2019-02035
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGCX1567
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1