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

Model Number	2557H24
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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.The device was not returned.
Event or Problem Description
It was reported that there was a puncture in the balloon surface after inserting the hematuria catheter and filling the balloon with liquid.Hence the catheter could not remain in place and was replaced by another.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned a potential root cause for this failure could be due to "§ imperfection in balloon due to process".The device was used for treatment, though it was unknown if the device was related to the reported event or met specifications since a sample was not returned.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: "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 within 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.Visually inspect the product for any imperfections or surface deterioration prior to use." 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
It was reported that there was a puncture in the balloon surface after inserting the hematuria catheter and filling the balloon with liquid.Hence the catheter could not remain in place and was replaced by another.

• Brand Name: BARDEX LUBRICATH HEMATURIA COUDE FOLEY CATHETER
• Common Device Name: HEMATURIA COUDE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11105626
• Report Number: 1018233-2020-22202
• Device Sequence Number: 19044348
• Product Code: KOD
• UDI-Device Identifier: 00801741025198
• UDI-Public: (01)00801741025198
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 2557H24
• Device Catalogue Number: 2557H24
• Device Lot Number: MYCXR153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/03/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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