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

Model Number 265714

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2020

Event Type  malfunction  

Event Description

It was reported that there was an alleged potential for death; however, the actual issue is unknown.Pulled from health canada¿s medical devices online databases.As per follow-up information received on 30aug2022, foley catheter did not drain for 6hours, and urine was noted to be bypassing.The user attempted to deflate balloon to remove from bladder which was unable to do so.The catheter clamped to detach when balloon popped inside bladder and the patient felt pain.Catheter was removed with piece of silicone that made up balloon missing.Cystoscopy had been ordered to remove piece of silicone from patient's bladder to prevent sepsis.

Manufacturer Narrative

He investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).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: "visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 3cc balloon: use 5cc sterile water, 5cc balloon: use 10cc sterile water, 15cc balloon: use 20cc sterile water, 20cc balloon: use 25cc sterile water, 30cc balloon: use 35cc sterile water, 40cc balloon: use 45cc sterile water, 75cc balloon: use 50cc sterile water, do not exceeded recommended capacities." to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.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 and adequately trained professional for assistance, as directed by hospital protocol." 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.

Event Description

It was reported that there was an alleged potential for death; however, the actual issue is unknown.Pulled from health canada¿s medical devices online databases.As per follow-up information received on 30aug2022, the foley catheter did not drain for 6 hours, and urine was noted to be bypassing.The user attempted to deflate the balloon to remove from the bladder, which was unable to do so.The catheter clamped to detach when the balloon popped inside the bladder and the patient felt pain.The catheter was removed with a piece of silicone that made up the balloon missing.Cystoscopy had been ordered to remove a piece of silicone from the patient's bladder to prevent sepsis.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).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: warning: do not use ointments or lubricants having a petroleum base.They will damage the latex.Visually inspected the product for any imperfections or surface deterioration prior to use.-use luer tip syringe to inflate with state 10ml 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.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.Allow the pressure within to balloon 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.The device was not returned.

Event Description

It was reported that there was an alleged potential for death; however, the actual issue is unknown.Pulled from health canada¿s medical devices online databases.As per follow-up information received on 30aug2022, the foley catheter did not drain for 6 hours, and urine was noted to be bypassing.The user attempted to deflate the balloon to remove from the bladder, which was unable to do so.The catheter clamped to detach when the balloon popped inside the bladder and the patient felt pain.The catheter was removed with a piece of silicone that made up the balloon missing.Cystoscopy had been ordered to remove a piece of silicone from the patient's bladder to prevent sepsis.

• Brand Name: BARD® FOLEY CATHETER SILICONE COATED
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15410134
• MDR Text Key: 305891062
• Report Number: 1018233-2022-07064
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741039584
• UDI-Public: (01)00801741039584
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 265714
• Device Catalogue Number: 123516A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• 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): Other