MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® ALL-SILICONE TEMP SENSING CATHETER; PEDIATRIC FOLEY CATHETER

Model Number 119108

Device Problem Deflation Problem (1149)

Patient Problems No Patient Involvement (2645); 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 foley catheter did not stay inflated prior to use on a patient.

Event Description

It was reported that the foley catheter did not stay inflated prior to use on a patient.

Manufacturer Narrative

The device was not returned for evaluation.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.Bard and bardex are registered trademarks of c.R.Bard, inc.Or an affiliate.C.R.Bard, inc.(b)(6) manufactured in mexico.".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® ALL-SILICONE TEMP SENSING CATHETER
• Type of Device: PEDIATRIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9403118
• MDR Text Key: 177406925
• Report Number: 1018233-2019-07663
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGCX4223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1