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

Model Number 119110

Device Problems Break (1069); Leak/Splash (1354); Split (2537)

Patient Problem Bacterial Infection (1735)

Event Date 12/28/2017

Event Type  Injury  

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.The device was not returned.

Event Description

It was reported that the temp sensing foley catheter broke "directly below where the catheter splits." the foley catheter was placed on (b)(6) 2017 and was then found to be broken and leaking from the break on (b)(6) 2017.On (b)(6) 2017 the patient was febrile and a urine sample was taken.The urine sample on (b)(6) 2018 tested positive for esbl producing e.Coli, resulting in a cauti.

Manufacturer Narrative

The reported issue (it was reported that the temp sensing foley catheter broke "directly below where the catheter splits." the foley catheter was placed on 12/23/2017 and was then found to be broken and leaking from the break on 12/28/2017.On 12/29/2017 the patient was febrile and a urine sample was taken.The urine sample on 01/01/2018 tested positive for esbl producing e.Coli, resulting in a cauti) was unconfirmed.Per visual inspection no defects were observed.Per functional evaluation the balloon was inflated with 3.5cc of a mix of tap water and blue methylene using a syringe and no leakage on catheter was found; after that, the balloon was injected with water by way of the drainage lumen and no leakage was noted.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: ¿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.Note: compatible only with the bard criticore monitor, bard urotrack 224 monitor, and other 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.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.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.Caution: as with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.".

Event Description

It was reported that the temp sensing foley catheter broke "directly below where the catheter splits." the foley catheter was placed on 12/23/2017 and was then found to be broken and leaking from the break on 12/28/2017.On 12/29/2017 the patient was febrile and a urine sample was taken.The urine sample on 01/01/2018 tested positive for esbl producing e.Coli, resulting in a cauti.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7259455
• MDR Text Key: 99596191
• Report Number: 1018233-2018-00402
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 119110
• Device Catalogue Number: 119110
• Device Lot Number: NGAW4605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR