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

Device Problems Failure to Power Up (1476); Device Handling Problem (3265)

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

Event Date 12/22/2022

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that registered nurse placed the foley and then the chemo drug, gemzar, was instilled in the bladder at 1132.There was a clamp placed on the foley tubing and registered nurse returned from lunch at 1230, another registered nurse reported that the clamp needed to be removed from the foley tubing at 1232 so that registered nurse removed the clamp from the foley and saw urine passing through the foley tubing.Later, the resident asked the registered nurse where the foley was.Registered nurse found the foley by the head of the bed and showed resident and noted that there was about 175 in the foley bag.Registered nurse reminded them that 50cc of gemzar had been instilled in the bladder, so they documented 125 of urine output.Around 1500 the robot was undocked, and the patient was repositioned, and at that time it was noted that the foley was on the ground.At 1505, resident replaced the foley and immediately 500cc of urine came out of the bladder into the newly placed bag.Surgeon was present and did not state that anything else needed to be done.Registered nurse asked resident how much urine output they had documented in total and they had charted the previous 125 for the 1130 output.Because of the chance that gemzar might have been in the bladder longer than the recommended one-hour instillation.

Event Description

It was reported that registered nurse placed the foley and then the chemo drug, gemzar, was instilled in the bladder at 1132.There was a clamp placed on the foley tubing and registered nurse returned from lunch at 1230, another registered nurse reported that the clamp needed to be removed from the foley tubing at 1232 so that registered nurse removed the clamp from the foley and saw urine passing through the foley tubing.Later, the resident asked the registered nurse where the foley was.Registered nurse found the foley by the head of the bed and showed resident and noted that there was about 175 in the foley bag.Registered nurse reminded them that 50cc of gemzar had been instilled in the bladder, so they documented 125 of urine output.Around 1500 the robot was undocked, and the patient was repositioned, and at that time it was noted that the foley was on the ground.At 1505, resident replaced the foley and immediately 500cc of urine came out of the bladder into the newly placed bag.Surgeon was present and did not state that anything else needed to be done.Registered nurse asked resident how much urine output they had documented in total and they had charted the previous 125 for the 1130 output.Because of the chance that gemzar might have been in the bladder longer than the recommended one-hour instillation.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.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.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN LATEX 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: 16973093
• MDR Text Key: 315873010
• Report Number: 1018233-2023-03626
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG