MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER INSERTION TRAY

Model Number 802030

Device Problem Component Missing (2306)

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

Event Date 12/16/2021

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 at least one of the foley catheter tray received was missing lubricant.It was also reported that the foley catheter was defective as the catheters patient had did not drain for a week and leaked.Nurse changed the foley and found the tip looked weird and the hole was small.It was also reported that the patient's current foley catheter was also leaking.It was noted that the patient had been using the products for less than 90 days.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It was unknown whether the device had met specifications.A potential root cause for this failure could be "machine speed out of parameters".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: a labeling review was not performed because labelling could not have prevented the reported failure.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 at least one of the foley catheter tray received was missing lubricant.It was also reported that the foley catheter was defective as the catheters patient had did not drain for a week and leaked.Nurse changed the foley and found the tip looked weird and the hole was small.It was also reported that the patient's current foley catheter was also leaking.It was noted that the patient had been using the products for less than 90 days.

• Brand Name: BARDIA® FOLEY CATHETER INSERTION TRAY
• Type of Device: FOLEY CATHETER INSERTION TRAY
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13110971
• MDR Text Key: 284901932
• Report Number: 1018233-2021-08514
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741018299
• UDI-Public: (01)00801741018299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 802030
• Device Catalogue Number: 802030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• 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: Female