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

Model Number	119218M
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Patient stated her silicon temp sensing foley catheter was leaking.The catheter was placed on (b)(6) 2020 and removed on (b)(6) 2020 as per additional information received via follow up email on 17 sep 2020, urine leaked and no impact to patient.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be "lumen to lumen leakage".A potential root cause for this failure could be due to "tubing design (walls not thick enough) / puncture".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "sterile: unless package is opened or damaged.Sterilized by ethylene oxide 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.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable laws and regulations.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Bard and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.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.Peel to open peel to open 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 temperature monitor 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 " h11: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.H3 other text : the device was not returned.
Event or Problem Description
Patient stated her silicon temp sensing foley catheter was leaking.The catheter was placed on (b)(6) 2020 and removed on (b)(6) 2020.As per additional information received via follow up email on 17sep2020, urine leaked and no impact to patient.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10605951
• Report Number: 1018233-2020-06255
• Device Sequence Number: 14111122
• Product Code: EZL
• UDI-Device Identifier: 00801741046315
• UDI-Public: (01)00801741046315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: Lay User/Patient
• Device Model Number: 119218M
• Device Catalogue Number: 119218M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1