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

Catalog Number 165812

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 the bladder scan showed 300mls, and the catheter of size 12 was still not draining.The user attempted to flush but met with resistance and unable to do so.The nursing team attempted to remove catheter but found it was getting caught despite deflation of balloon, 9ml water withdrawn into 10ml syringe.The doctor attempted to withdraw further fluid from balloon but would not drain further.They were able to advance catheter but when trying to withdraw feels like it was getting caught and unable to withdraw any further.The patient reacting with flexion in response to this despite propofol, clear discomfort.They attempted use of instillagel to facilitate removal and moving the penis but did not help.Whilst manoeuvring the patient would bypass the catheter, but this would stop after.The doctor discussed with urology registrar.They advised that they were unsure of the most appropriate course of action in this situation and did not feel that the patient would not benefit from their review at this time as they would be unlikely to remove the catheter if they had failed with above techniques.Suggested patient might need imaging but that best course was for them to contact their consultant for further advise as they had not seen the patient themselves.The doctor discussed with urology consultant.They advised that this situation was not uncommon and that the most appropriate course of action would be to ensure adequate analgesia and to pull the catheter out utilising more force despite risk of urethral trauma.Imaging would not change management at this stage.In eventuality that catheter broke and became retained they would be able to remove at a later stage if required.They suggested that a likely problem would be re-catheterisation after removal, and if this was the case then they could recontact the registrar for flexi-cystoscopy and catheter replacement if required.They reattempted removal of catheter.Patient sedation increased.The catheter removed relatively easily, with minimal force, balloon at the tip was still partially inflated, and unable to be deflated on removal.Re-catheterised with size 18 three-way catheter using aseptic non-touch technique (antt).They were unable to pass size 14 or 16.Good volume of urine drained immediately.Some evidence of urethral trauma with some small blood clots were present.

Event Description

It was reported that the bladder scan showed 300mls, and the catheter of size 12 was still not draining.The user attempted to flush but met with resistance and unable to do so.The nursing team attempted to remove catheter but found it was getting caught despite deflation of balloon, 9ml water withdrawn into 10ml syringe.The doctor attempted to withdraw further fluid from balloon but would not drain further.They were able to advance catheter but when trying to withdraw feels like it was getting caught and unable to withdraw any further.The patient reacting with flexion in response to this despite propofol, clear discomfort.They attempted use of instillagel to facilitate removal and moving the penis but did not help.Whilst manoeuvring the patient would bypass the catheter, but this would stop after.The doctor discussed with urology registrar.They advised that they were unsure of the most appropriate course of action in this situation and did not feel that the patient would not benefit from their review at this time as they would be unlikely to remove the catheter if they had failed with above techniques.Suggested patient might need imaging but that best course was for them to contact their consultant for further advise as they had not seen the patient themselves.The doctor discussed with urology consultant.They advised that this situation was not uncommon and that the most appropriate course of action would be to ensure adequate analgesia and to pull the catheter out utilising more force despite risk of urethral trauma.Imaging would not change management at this stage.In eventuality that catheter broke and became retained they would be able to remove at a later stage if required.They suggested that a likely problem would be re-catheterisation after removal, and if this was the case then they could recontact the registrar for flexi-cystoscopy and catheter replacement if required.They reattempted removal of catheter.Patient sedation increased.The catheter removed relatively easily, with minimal force, balloon at the tip was still partially inflated, and unable to be deflated on removal.Re-catheterised with size 18 three way catheter using aseptic non touch technique (antt).They were unable to pass size 14 or 16.Good volume of urine drained immediately.Some evidence of urethral trauma with some small blood clots were present.As per the follow-up information received on 02jan2024, the customer has provided a photo sample showing the partially deflated balloon.According to them, the photographs clearly demonstrate the fault in terms of a deformed balloon that will not deflate below a certain volume.They would speculate that the deformity has created a one-way valve effect that is overcome at a greater volume.They were unable to deflate the balloon.Although they were able to inflate it further and remove the added water down to the initial volume.They confirmed that the corporate lot was #myhn1895.Unfortunately, the catheter had to be removed with the balloon partial inflated.This resulted in urethral trauma, pain, and bleeding.They classified the harm as minor, although they are waiting to hear of any longer-term consequences.The patient was re-catheterized with a larger, size 18 urinary catheter.

Manufacturer Narrative

The reported event was inconclusive.Visual evaluation of the returned photo samples noted one opened (without original packaging) used silicone foley.The catheter balloon was evidenced partially inflated and asymmetrical.The report event is considered inconclusive, since the conditions of the sample did not allow further evaluation in regards the inaccurate flow report.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be lumen collapse.However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 silicone.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.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.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.Single use only.Do not resterilize 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." correction: d 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18464903
• MDR Text Key: 332378714
• Report Number: 1018233-2023-09540
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 165812
• Device Lot Number: MYHN1895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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