MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP; FOLEY CATHETER (LATEX)

Model Number 0168L14

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter spontaneously fell out.

Manufacturer Narrative

The event was unconfirmed.There were no visual defects noted.No holes in the balloon were noted.The device was inflated with a 10 cc luer lock syringe.It was allowed to sit for one minute.No leakage was noted.The 10cc luer lock syringe was reinserted and the device deflated with no issues.A device history record review was not required per the investigation.A labeling review was not completed as the only the manufacturing lot number was given.After the lot is released it is sent to be placed in products such as a single strip packages, multiple trays, and other product subassemblies.These products have various labeling which cannot be determine without the associated corporate lot# or packaging.

Event Description

It was reported that the catheter spontaneously fell out.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8542032
• MDR Text Key: 142932514
• Report Number: 1018233-2019-02136
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017810
• UDI-Public: (01)00801741017810
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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 Expiration Date: 02/11/2023
• Device Model Number: 0168L14
• Device Catalogue Number: 0168L14
• Device Lot Number: MCCP0364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1