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

Device Problem Off-Label Use (1494)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The reported event is confirmed misapplication/ user error based on the event description.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.

Event Description

It was reported that 4 patients have had to return to the hospital over the past two years following use of the foley tray kit.The patients experienced vaginal and rectal pain due to the swab stick included with the kit, being left inside of the patient after use.

• Brand Name: FOLEY TRAYS
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9318253
• MDR Text Key: 166494454
• Report Number: 1018233-2019-07298
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• 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