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

Model Number 119216M

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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 temp sensing catheter did not produce accurate readings.The complainant stated the patient was normothermic.However, despite checking/adjusting the equipment, the reading was 94.5f.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause is "sensor wire too weak or thermistor chip too weak".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: "for urological use only single use only do not resterilize.Note: compatible with appropriate 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.Caution: as with all temperature probes: in the presence of rf energy sources: local heating, temperature errors, and probe damage may occur.In medical use, unplug the temperature-sensing catheter at the extension cable before activating electrosurgical or other types of direct coupled rf energy sources.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.Valve type: use luer slip syringe.Do not use needle.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the temp sensing catheter did not produce accurate readings.The complainant stated the patient was normothermic.However, despite checking/adjusting the equipment, the reading was 94.5f.No medical intervention was reported.

• 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: 9465613
• MDR Text Key: 178748119
• Report Number: 1018233-2019-07946
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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: 11/30/2021
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGDU1907
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1