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

Model Number 0165SI16

Device Problems Deflation Problem (1149); Material Fragmentation (1261); Material Rupture (1546); No Flow (2991)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2019

Event Type  Injury  

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 it was difficult to deflate the balloon 1.5 hour after placement, because there was no urine flow.The user attempted to remove the catheter.The balloon was ruptured by injecting water.It was later reported, per additional information received via email on 14 may 19 from the ibc, there were missing pieces of the balloon.A ct scan was performed; however, no fragments were found by the facility.

Event Description

It was reported that it was difficult to deflate the balloon 1.5 hour after placement, because there was no urine flow.The user attempted to remove the catheter.The balloon was ruptured by injecting water.It was later reported, per additional information received via email on 14 may 19 from the ibc, there were missing pieces of the balloon.A ct scan was performed; however, no fragments were found by the facility.

Manufacturer Narrative

The investigation of the reported event was inconclusive.Only the catheter was received, cut into 3 pieces without the valve and cap.The sac was observed to be burst as the user tried to attempt to remove out the catheter.Due to the poor sample condition of the returned sample, a complete evaluation could not be performed.How and when problem occurred could not be determined.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: "1.Precautions for use (1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.(2) when deflating balloon, do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.]".

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8646708
• MDR Text Key: 146262287
• Report Number: 1018233-2019-02743
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165SI16
• Device Catalogue Number: 0165SI16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR