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

Model Number	0094160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
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.
Event or Problem Description
It was reported that the drainage hole on the catheter was near the tip and the tip bent easily when given a little force.There was no patient injury.
Additional Manufacturer Narrative
Upon further review, bard/bd has determined that this mdr was initially reported in error as this event is not reportable.
Event or Problem Description
It was reported that the drainage hole on the catheter was near the tip and the tip bent easily when given a little force.There was no patient injury.

• Brand Name: BARD® ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8377342
• Report Number: 1018233-2019-01067
• Device Sequence Number: 16638162
• Product Code: KOD
• UDI-Device Identifier: 00801741034039
• UDI-Public: (01)00801741034039
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: Health Professional
• Device Model Number: 0094160
• Device Catalogue Number: 0094160
• Device Lot Number: NGCW1495
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1