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

Model Number 119108

Device Problems Material Invagination (1336); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that upon removal, there was a cuff roll on the balloon of the catheter.This event occurred on the third day of usage and the patient experienced self limited pain.

Event Description

It was reported that upon removal, there was a cuff roll on the balloon of the catheter.This event occurred on the third day of usage and the patient allegedly experienced self limited pain.

Manufacturer Narrative

The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (no original packaging present), used pediatric silicone catheter present.No obvious cuff or ridge was present on the catheter balloon upon sample receipt.Catheter balloon was inflated with 3.5ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) with no resistance or difficulty to inflation.Catheter was allowed to sit for 10 minutes before deflation.Catheter fully deflated 3.5ml of methylene blue solution (with negligible remnants in the balloon) with no observable cuffing or ridges in the balloon.After inflation and deflation, active length of the catheter balloon was measured (0.4920") and found to be within specification (0.4" +/- 0.1").French size of the balloon was measured to be 10 fr, while the catheter was measured to be 8fr.This difference was within the +4 fr size specification limit.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿bardex® latex-free temperature-sensing 400-series foley catheter mri safety instructions warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.Refer to instructions for use! it is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.Non-clinical testing demonstrated that these foley catheters with temperature sensors are mr conditional.A patient with one of these devices can be scanned safely immediately after placement under the following conditions: - static magnetic field of 3-tesla or less with regard to magnetic field interactions.- spatial gradient magnetic field of 720-gauss/cm or less with regard to magnetic field interactions.- maximum mr system reported whole-body-averaged specific absorption rate (sar) of 3.5-w/kg at 1.5- or 3-w/kg at 3-tesla for 15 minutes of scanning.Special instructions: the position of the wire of the foley catheter with temperature sensor has an important effect on the amount of heating that may develop during an mri procedure.Accordingly, the foley catheter with temperature sensor must be positioned in a straight configuration down the center of the patient table (i.E., down the center of the mr system without any loop) to prevent possible excessive heating associated with an mri procedure.Importantly, the mri procedure should be performed using an mr system operating at a static magnetic field strength of 1.5-tesla or 3-tesla, only.The safe use of an mr system operating at lower or higher field strength for a patient with a foley catheter with temperature sensor has not been determined.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.¿.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: FOLEY (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7567531
• MDR Text Key: 110140198
• Report Number: 1018233-2018-02044
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGBP4725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1