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

Model Number	2557H24
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	01/20/2020
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 catheter got stuck in the patient's urethra.The catheter was removed by surgery.
Event or Problem Description
It was reported that the catheter got stuck in the patient's urethra.The catheter was removed by surgery.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be due to a "pinched lumen".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: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.English warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Units 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.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.Do not use if package is damaged.Bard, bardex, bardia, biocath and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use only.Do not reuse.Do not resterilize consult instructions for use.Bd switzerland sàrl terre bonne park ¿ a4 route de crassier 17 1262 eysins, switzerland c.R.Bard, inc.Covington, ga 30014 usa 1 800 526 4455 www.Bardmedical.Com manufacturer: 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 necessary, 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." 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.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER
• Common Device Name: HEMATURIA FOLEY CATHETERS (POST-OP CATHETER)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9701924
• Report Number: 1018233-2020-00992
• Device Sequence Number: 11368433
• Product Code: KOD
• UDI-Device Identifier: 00801741025198
• UDI-Public: (01)00801741025198
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2557H24
• Device Catalogue Number: 2557H24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/23/2020
• 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