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

Model Number	119112
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon could not be inflated as the sterilized water was injected, due to water leakage from an unknown part of the catheter.Per follow-up information received from ibc on 06dec2021, stated that the catheter fell out because balloon did not inflate.Per sample evaluation results received on 27may2022, it was reported that the inflation notch on the foley catheter was found to be too small.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the foley catheter balloon could not be inflated as the sterilized water was injected, due to water leakage from an unknown part of the catheter.Per follow-up information received from ibc on 06dec2021, stated that that the catheter fell out because balloon did not inflate.Per sample evaluation results received on 27may2022, it was reported that the inflation notch on the foley catheter was found to be too small.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1sample were confirmed to exhibit the reported failure.The reported failure is considered out of specification as the reported failure was reproduced.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used three-way temp sensing foley catheter.Visual inspection of the sample noted attempt to inflate the balloon with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) observed the solution backing up in the catheter shaft and leaked out of the eyelet confirming a lumen to lumen leakage.This is considered a failure "cuts in lumens are not allowed.The eyes piercing must not penetrate the inflation lumen and must be properly formed.Bends are not allowed in the inflation lumen." also noted dissected the balloon to verify the notch perforation noted that the notch measuring (0.015") on the return sample.This is consider a failure "verify that the eyes piercing is complete".A potential root cause for this failure mode could be ¿notch design (id undersized) § notch placement (nicks drainage lumen)§ no notch".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: "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.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through the drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.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.For urological use only.Valve type: use luer slip syringe.Do not use needle.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.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone balloon 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.Note: compatible only with the bard criticore monitor, bard urotrack 224 monitor, and other 400-series temperature monitors.Interchangeability + 0.2oc at 37oc." h11: section a through f - 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14732618
• Report Number: 1018233-2022-04710
• Device Sequence Number: 5800699
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2025
• Device Model Number: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGEW1921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown