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

Model Number 1758SI16

Device Problem Calcified (1077)

Patient Problems Muscle Spasm(s) (1966); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/16/2021

Event Type  malfunction  

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 patient was allergic to latex and inquired if there were any type of latex free catheter.Patient got the catheter changed every 4 weeks in the cdu at a local hospital since there were buildup in the catheter and bag tubing due to medications.Therefore, patient had to flush it every week sometimes more which caused cramping in the bladder.Patient was consuming large amount of potassium and the catheter was in place since (b)(6) 2020 and it had not collected in the bay tubing.Patient stopped using it due to swelling and irritation.It was noted that the catheter got changed on (b)(6) 2021.No medical intervention was reported.Hx: patient was allergic to latex and was consuming large amounts of potassium medication.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this failure mode could be user related (example: salt accumulation)/ block drainage lumen/ no or undersize drainage eye.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the foley catheter product ifus were found to be adequate based on past reviews.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 was allergic to latex and inquired if there were any type of latex free catheter.The patient got the catheter changed every 4 weeks in the clinical decision unit (cdu) at a local hospital since there were buildup in the catheter and bag tubing due to medications.Therefore, patient had to flush it every week sometimes more which caused cramping in the bladder.The patient was consuming large amount of potassium and the catheter was in place since (b)(6) 2020 and it had not collected in the bay tubing.The patient stopped using it due to swelling and irritation.It was noted that the catheter got changed on (b)(6) 2021.No medical intervention was reported.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11302877
• MDR Text Key: 231116493
• Report Number: 1018233-2021-00366
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1758SI16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other