MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER

Model Number	0167SI20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
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
It was reported that the survey respondent was asked whether they believe the benefits of using the product outweigh the potential risks in relation to the bardex i.C.3-way irrigation foley catheter as part of a customer survey.The respondent indicated that no, the benefits of using this product do not outweigh the potential risks.When asked to elaborate, the respondent stated urethral injury.It was unknown what medical intervention was provided for urethral injury (0167si16, 0167si18, 0167si20, 0167si22, 0167si24, 0167si26).
Event or Problem Description
It was reported that the survey respondent was asked whether they believe the benefits of using the product outweigh the potential risks in relation to the bardex i.C.3-way irrigation foley catheter as part of a customer survey.The respondent indicated that no, the benefits of using this product do not outweigh the potential risks.When asked to elaborate, the respondent stated urethral injury.It was unknown what medical intervention was provided for urethral injury (0167si16, 0167si18, 0167si20, 0167si22, 0167si24, 0167si26).
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿tortuous anatomy".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: federal (usa) law restricts this device to sale by or on the order of a physician.Do not use if package is damaged.Indications for use: the bardex® i.C.Latex foley catheter is indicated for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.Directions for use: 1.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.2.Using proper aseptic methods, remove catheter from package.3.Prepare patient per hospital/nursing recommended procedure.4.Proceed with catheterization using standard techniques.5.Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled luer tip syringe.6.Connect catheter to collection container.7.To deflate the balloon, gently reinsert the luer tip syringe into the valve and aspirate.Caution: to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure in the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.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.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and /or lead to injury, illness or death of the patient.Valve type: use luer slip tip syringe.Do not use needle.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: do not aspirate urine through drainage funnel.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.After use, this product may be a potential biohazard." correction: g.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15980701
• Report Number: 1018233-2022-09520
• Device Sequence Number: 20570751
• Product Code: MJC
• UDI-Device Identifier: 00801741017308
• UDI-Public: (01)00801741017308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0167SI20
• Device Catalogue Number: 0167SI20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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