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

Model Number 119208M

Device Problems Misassembled (1398); Defective Device (2588)

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.

Event Description

It was reported that the 8 fr temp-sensing foley was found to be not patent after attempted insertion in a patient.Per additional information received, the foley did not drain.When the urologist came to assist, he examined the foley after the removal and there was no hole in the end of the foley for the urine to drain out.

Event Description

It was reported that the 8fr temp-sensing foley was found to be not patent after attempted insertion in a patient.Per additional information received, the foley did not drain.When the urologist came to assist, he examined the foley after the removal and there was no hole in the end of the foley for the urine to drain out.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿no eyes¿ with a potential root cause of "inadequate process".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: ¿additional safety instructions include the following: 1.The foley catheter with temperature sensor should not be connected to the temperature monitoring equipment during the mri procedure.2.If the foley catheter with temperature sensor has a removable catheter connector cable, it should be disconnected prior to the mri procedure.3.Remove all electrically conductive material from the bore of the mr system that is not required for the procedure (i.E., unused surface coils, cables, etc.).4.Keep electrically conductive material that must remain in the bore of the mr system from directly contacting the patient by placing thermal and/or electrical insulation (including air) between the conductive material and the patient.5.Position the foley catheter with a temperature sensor in a straight configuration down the center of the patient table to prevent cross points and conductive coils or loops.6.The wire and connector of the foley catheter with temperature sensor should not be in contact with the patient during the mri procedure.Position the device, accordingly.7.Mr imaging should be performed using an mr system with static magnetic strength of 1.5-tesla or 3-tesla, only.8.At 1.5-tesla, the mr system whole body averaged sar should not exceed 3.5- w/kg for 15-min.Of scanning.9.At 3-tesla, the mr system reported whole body averaged sar should not exceed 3-w/kg for 15-min of scanning." 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 TEMP SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9856402
• MDR Text Key: 186334634
• Report Number: 1018233-2020-01959
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046261
• UDI-Public: (01)00801741046261
• 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
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 119208M
• Device Catalogue Number: 119208M
• Device Lot Number: NGDU1415
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1