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

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

It was reported that the patient tried to deflate the foley catheter balloon, but it was not working.Representative advised troubleshooting steps and it took thirty seconds for the water to flow through the small diameter inflation lumen and if they notice slow or no deflation then re-seat the syringe gently and once again allow the balloon to deflate slowly on its own, if the balloon did not deflate then reposition the patient and to ensure that the catheter was not in traction and the proximal end of the catheter was not compressed within the bladder neck and then attempt to deflate the balloon n by using the pressure in the balloon to force water into the syringe as described above.If the balloon still failed to deflate, then apply very gentle slow aspiration.Aspiration that was too rapid or too forceful might cause the inflation lumen within the foley catheter to collapse.If permitted by hospital protocol, the valve arm might be severed and if this fails contact an adequately trained professional for assistance, as directed by hospital protocol and non-deflating foleys should be reported to product complaints.

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 patient tried to deflate the foley catheter balloon, but it was not working.Representative advised troubleshooting steps and it took thirty seconds for the water to flow through the small diameter inflation lumen and if they notice slow or no deflation then re-seat the syringe gently and once again allow the balloon to deflate slowly on its own, if the balloon did not deflate then reposition the patient and to ensure that the catheter was not in traction and the proximal end of the catheter was not compressed within the bladder neck and then attempt to deflate the balloon n by using the pressure in the balloon to force water into the syringe as described above.If the balloon still failed to deflate, then apply very gentle slow aspiration.Aspiration that was too rapid or too forceful might cause the inflation lumen within the foley catheter to collapse.If permitted by hospital protocol, the valve arm might be severed and if this fails contact an adequately trained professional for assistance, as directed by hospital protocol and non-deflating foleys should be reported to product complaints.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable 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: UNKNOWN FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17772899
• MDR Text Key: 323715973
• Report Number: 1018233-2023-06879
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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