MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DUAL LUMEN URETERAL CATHETER

Model Number 130200

Device Problem Leak/Splash (1354)

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 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.The device was not returned.

Event Description

It was reported that the catheter leaked.

Manufacturer Narrative

The device was not returned for evaluation.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: ¿directions for use: the ureteral catheter should be inserted into the ureter using standard endourologic technique, under direct, fluoroscopic or radiographic visualization.Caution: avoid sharp bending.".

Event Description

It was reported that the catheter leaked.

• Brand Name: BARD® DUAL LUMEN URETERAL CATHETER
• Type of Device: DUAL LUMEN URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8776094
• MDR Text Key: 150697945
• Report Number: 1018233-2019-03794
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 00801741052903
• UDI-Public: (01)00801741052903
• Combination Product (y/n): N
• PMA/PMN Number: K032521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 130200
• Device Catalogue Number: 130200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1