MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Model Number 175806N

Device Problem Calcified (1077)

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

Event Date 03/18/2022

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 urine was noted to be draining from balloon port of foley catheter.The user attempted to aspirate from balloon port for small amount of urine.The balloon was found to be ruptured and had sediments on the tip when the foley catheter was removed.There were no complications when another foley catheter was placed.The user was not able to determine whether the parts of balloon remained inside the patient and it was noted that the balloon material appeared to be intact.

Event Description

It was reported that urine was noted to be draining from balloon port of foley catheter.The user attempted to aspirate from balloon port for small amount of urine.The balloon was found to be ruptured and had sediments on the tip when the foley catheter was removed.There were no complications when another foley catheter was placed.The user was not able to determine whether the parts of balloon remained inside the patient and it was noted that the balloon material appeared to be intact.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14112708
• MDR Text Key: 289279366
• Report Number: 1018233-2022-02475
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034268
• UDI-Public: (01)00801741034268
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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 Model Number: 175806N
• Device Catalogue Number: 175806N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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