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

Model Number	0167SI22
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
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.
Event or Problem Description
It was reported that 2 of the foley were unable to hook up the syringe properly.Per follow up information received on 12dec2020, stated that 2 catheter was opened and the syringe was not attached to the balloon port on the field then used a different size 3-way catheter on patient and kept all the 6 for testing.
Event or Problem Description
It was reported that 2 of the foley were unable to hook up the syringe properly.Per follow up information received on (b)(6) 2020, stated that 2 catheter was opened and the syringe was not attached to the balloon port on the field then used a different size 3-way catheter on patient and kept all the 6 for testing.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The reported failure is considered within specification as the reported failure could not be reproduced.The product was used for treatment.The product had not caused the reported failure.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: "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." corrections: d,h 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 evaluated.

• 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
• MDR Report Key: 11092803
• Report Number: 1018233-2020-22132
• Device Sequence Number: 4042673
• Product Code: MJC
• UDI-Device Identifier: 00801741017315
• UDI-Public: (01)00801741017315
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Expiration Date: 01/31/2025
• Device Model Number: 0167SI22
• Device Catalogue Number: 0167SI22
• Device Lot Number: NGEU2461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other