MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY; DRAIN BAG 153520JR IS PART OF THE TRAY 7760014LR

Catalog Number 153520JR

Device Problem Partial Blockage (1065)

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

Event Date 08/09/2022

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 when the user tried to wash the drain bag with water after use, it was found to be clogged with water.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be generated from supplier side or kink inlet tube/no air vent/design issue.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: "indication for use 1.Take off the drainage bag cap with careful for sterile of inlet tube.Then connect with foley catheter 2.Fix the drainage bag securely on the patient bed etc.Using the hanger/belt to prevent the bag from sudden movement and to avoid direct contact with floor.Keep the drainage bag below the level of patient bladder to keep urine flowing freely.3.Drain tubing must be secured using sheeting clip, keeping the tubing line straight with no kink to avoid obstructed urine flow into drainage bag.Kinked of or flexed drain tubing will restrict urine flow.4.Lift cock up and pass urine precautions 1.Do not let the distal end of the outlet tube touch the urine collection container when emptying the bag in order not to permit bacterial contamination into drainage bag.2.Care should be taken where the bag should be positioned to avoid damage by bump or projection.3.Do not pull outlet tube on urinating.It might break the product." the device was not returned.

Event Description

It was reported that when the user tried to wash the drain bag with water after use, it was found to be clogged with water.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Type of Device: DRAIN BAG 153520JR IS PART OF THE TRAY 7760014LR
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15252026
• MDR Text Key: 305004233
• Report Number: 1018233-2022-06546
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910318
• 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: 09/01/2022

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: Health Professional
• Device Catalogue Number: 153520JR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/08/2022
• 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
• Patient Sex: Male