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

Model Number	130200
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the instructions on the device were inadequate.The customer alleged the instructions for use described the device itself and product warnings but very little about potential clinical application.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be due to "missing instructions".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: ¿the ureteral catheter should be inserted into the ureter using standard endourologic technique, under direct, fluoroscopic or radiographic visualization.Caution: avoid sharp bending.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.
Event or Problem Description
It was reported that the instructions on the device were inadequate.The customer alleged the instructions for use described the device itself and product warnings but very little about potential clinical application.

• Brand Name: BARD® DUAL LUMEN URETERAL CATHETER
• Common Device Name: DUAL LUMEN CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8775997
• Report Number: 1018233-2019-03790
• Device Sequence Number: 2665978
• Product Code: EYB
• UDI-Device Identifier: 00801741052903
• UDI-Public: (01)00801741052903
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K032521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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
• Operator of Device: Other
• Device Model Number: 130200
• Device Catalogue Number: 130200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1