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

Model Number	0094160
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the catheters had sharp eyes.The patient saved the catheters but did not use them.
Additional 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: ¿contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Single use do not resterilize warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." 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 or Problem Description
It was reported that the catheters had sharp eyes.The patient saved the catheters, but did not use them.

• Brand Name: BARD® ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8359194
• Report Number: 1018233-2019-00927
• Device Sequence Number: 1620782
• Product Code: KOD
• UDI-Device Identifier: 00801741034039
• UDI-Public: (01)00801741034039
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: Lay User/Patient
• Device Model Number: 0094160
• Device Catalogue Number: 0094160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1