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

Model Number 119110

Device Problems Entrapment of Device (1212); Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

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 thermistor wire was snaked within the lumen.

Manufacturer Narrative

The reported event was confirmed but the cause could not be determined.The inspector received one silicone temperature sensing catheter.A wire was noted to be protruding out of the trifurcation area with the wire snaking throughout the entire length of the catheter.The thermistor tip was not in the tip of the 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: "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." 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 thermistor wire was snaked within the lumen.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8329180
• MDR Text Key: 136248131
• Report Number: 1018233-2019-00737
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046001
• UDI-Public: (01)00801741046001
• 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: 05/09/2019

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: 02/28/2022
• Device Model Number: 119110
• Device Catalogue Number: 119110
• Device Lot Number: NGBP2628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1