MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH TEMPERATURE SENSING FOLEY CATHETER; TEMP SENSING CATHETER

Model Number 119418M

Device Problems Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023); Component Misassembled (4004)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 asked why the temp sensing foley product did not perform as intended, the respondent said it was the position for the drainage.

Event Description

It was reported that when asked why the temp sensing foley product did not perform as intended, the respondent said it was the position for the drainage.

Manufacturer Narrative

The reported event was inconclusive.A potential root cause could be due to an "operator error" during the punching process.As no sample was returned, it cannot be determined if the device met specifications or its relationship with reported event.Based on the reported event, it is unknown if the device was used for treatment or diagnosis.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use".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 LUBRICATH TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10007418
• MDR Text Key: 189470232
• Report Number: 1018233-2020-02914
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741046155
• UDI-Public: (01)00801741046155
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 119418M
• Device Catalogue Number: 119418M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1