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

Model Number 0165L18

Device Problem Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Code Available (3191)

Event Date 12/02/2020

Event Type  Injury  

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 the patient was a hard sleeper and rolled back forth to the stomach, this caused the catheter to leak.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: b, d, h.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.

Event Description

It was reported that the patient was a hard sleeper and rolled back and forth to the stomach and this caused the catheter to leak.Per follow up via phone on (b)(6) 2020, the customer inflated the balloon with 9cc, but it hits the nerve, so started to inflate with 7cc when the leakage was started.The patient reportedly developed infection as a result of the catheters were leaking which resulted in blood poisoning.The patient received a blood transfusion and antibiotics at the hospital and the patient¿s urologist recommended in changing the catheters every 21 days.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10877307
• MDR Text Key: 217463266
• Report Number: 1018233-2020-21129
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017490
• UDI-Public: (01)00801741017490
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0165L18
• Device Catalogue Number: 0165L18
• Device Lot Number: NGEV4380
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention