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

Model Number 0165SI22

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

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 catheters got clogged up sometimes.

Event Description

It was reported that the foley catheters got clogged up sometimes.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.However, the potential root cause for this failure mode could be user related (example: salt accumulation)/ blocked drainage lumen/ no drainage eye.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: "proper technique for urinary catheter maintenance.- secure the foley catheter.Use the statlock foley stabilization device if provided.- maintain a closed drainage system by utilizing pre-connected, sealed, catheter-tubing junctions.- maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.- keep the collection bag below the level of the bladded or hips at all times.- empty the collection bag regularly using a separate, clean collection container for each patient." 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.H3 other text : the device was not returned.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10658697
• MDR Text Key: 210712585
• Report Number: 1018233-2020-20047
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016783
• UDI-Public: (01)00801741016783
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0165SI22
• Device Catalogue Number: 0165SI22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 01/23/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other