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

Device Problem Device Handling Problem (3265)

Patient Problems Nausea (1970); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the suprapubic catheter balloon was misplaced in the bladder and this prevented the urine from draining out.

Event Description

It was reported that the suprapubic catheter balloon was misplaced in the bladder and prevented urine from draining out.During last fifteen years the patient had regular suprapubic catheter replacement uneventfully.Last replacement performed 10 days earlier.The patient contacted the family physician with uremic presentation of malaise and nausea with diminished urine output per catheter, with no urine leakage otherwise.Upon referral to the hospital, the patient underwent preliminary evaluation, including catheter flushing, which reported to be difficult with no residual volume.A computed tomography test was performed, demonstrating bilateral hydroureteronephrosis, with an empty bladder.The tip of the suprapubic catheter located inside left ureteral orifice, for a few cm long.This way catheter drainage holes were all inside the distal left ureter, which interferes with the drainage of urine from both kidneys.The catheter balloon that was in the bladder and prevented urine from draining out.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.As the reported event does not include specific details on how the catheter was placed by the user, it is unknown at this time if the event was caused by misplacement of the catheter or by the catheter moving after placement causing obstruction of the ureter.The potential failure mode for this failure user uses catheter for off label use.The potential root cause for this failure could be due to user violation of standard practice; the potential failure mode for this failure catheter inserted too far into bladder.The potential root cause for this failure could be due to user violation of standard practice.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: the product catalog number and lot number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.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 device was not returned.

• Brand Name: LATEX 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12584212
• MDR Text Key: 274979785
• Report Number: 1018233-2021-06249
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• 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; Required Intervention