MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE

Model Number 0102L16

Device Problem Incorrect Measurement (1383)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported that the patient had noticed a difference in the diameter at the base of the foley catheter where it joined to the funnel area, but up from there a couple inches.No additional information provided.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text: the device was not returned.

Event Description

It was reported that the patient had noticed a difference in the diameter at the base of the foley catheter where it joined to the funnel area, but up from there a couple inches.No additional information provided.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "error of inspector".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required because a review of the label could not have prevented this issue.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Type of Device: FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16808394
• MDR Text Key: 313934713
• Report Number: 1018233-2023-02850
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0102L16
• Device Catalogue Number: 0102L16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• 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