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

Model Number 123516A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the foley catheter was moving up and down since the patient did not have any foley stabilization device which resulted in bacterial infection inside the patient's urethra.Patient stated that it had caused two urinary tract infections and experienced bleeding.It was unknown what medical intervention was provided for the urinary tract infection and bleeding.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this reported event could be due to bacterial infection, long indwelling time, surface irregularities.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: "single use only.Do not resterilize, for urological use only." correction: b.H11:section a through f - the information provided by bd represents all of 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 foley catheter was moving up and down since the patient did not have any foley stabilization device which resulted in bacterial infection inside the patient's urethra.Patient stated that it had caused two urinary tract infections and experienced bleeding.It was unknown what medical intervention was provided for the urinary tract infection and bleeding.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10801601
• MDR Text Key: 215060452
• Report Number: 1018233-2020-20779
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095092
• UDI-Public: (01)00801741095092
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 123516A
• Device Catalogue Number: 123516A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other