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

Model Number 0102L16

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2022

Event Type  Injury  

Event Description

It was reported that a patient pulled out his foley catheter, and the nursing staff noticed the bulb and tip were missing.Urology was consulted for a cystoscopy.Per additional information received via email on (b)(6)2022, the clinical practice manager stated the catheter was inserted on (b)(6)2022.On (b)(6)2022, the patient was confused and pulled the catheter out.On (b)(6) 2022, urology ordered a cystoscopy.Per follow up information received via email on (b)(6) 2022, the clinical practice manager stated the foreign body was not removed as the patient¿s condition was too poor for surgery.The patient passed away on (b)(6) 2022.No additional information was provided.Clinical follow ups were attempted via email on (b)(6) 2022 and (b)(6) 2022.Another clinical follow up via phone was attempted on (b)(6) 2022.Despite good faith efforts, no additional information has been received.There was no indication that the death was related to the device.Received follow up email on (b)(6) 2022 from vp of medicine stating the facility is not able to share some of the information requested for privacy reasons.No additional information received.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was confirmed use related as the customer pulled out his foley catheter.No sample was returned for evaluation.A potential root cause for this failure could be ¿user (patient) medicated, delirious, confused, or reckless/ user oversight, user did not follow procedure¿.It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.The device was not returned for evaluation.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: "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".The baw is attached on the investigation overview element." 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.

Event Description

It was reported that a patient pulled out the foley catheter, and the nursing staff noticed the bulb and tip were missing.Urology was consulted for a cystoscopy.Per additional information received via email on (b)(6) 2022, the clinical practice manager stated the catheter was inserted on (b)(6) 2022.On (b)(6) 2022, the patient was confused and pulled the catheter out.On(b)(6) 2022, urology ordered a cystoscopy.Per follow up information received via email on (b)(6) 2022, the clinical practice manager stated the foreign body was not removed as the patient¿s condition was too poor for surgery.The patient passed away on (b)(6) 2022.No additional information was provided.Clinical follow ups were attempted via email on (b)(6) 2022 and (b)(6) 2022.Another clinical follow up via phone was attempted on (b)(6) 2022.Despite good faith efforts, no additional information has been received.There was no indication that the death was related to the device.Received follow up email on (b)(6) 2022 from vp of medicine stating the facility is not able to share some of the information requested for privacy reasons.No additional information received.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Type of Device: FOLEY CATHETER TIEMANN MODEL COUDE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13715682
• MDR Text Key: 286932802
• Report Number: 1018233-2022-01183
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Model Number: 0102L16
• Device Catalogue Number: 0102L16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention