MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARDEX® LUBRICATH® FOLEY CATHETER

Model Number	0166L16
Health Effect - Clinical Code	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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the balloon won't stay inflated.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error on a 3500a form.The reported event was found to be exempt from reporting, per exemption e1998006.H11:section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the balloon won't stay inflated.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• MDR Report Key: 6578731
• Report Number: 1018233-2017-02540
• Device Sequence Number: 91221
• Product Code: KOD
• UDI-Device Identifier: 00801741017582
• UDI-Public: (01)00801741017582
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: 0166L16
• Device Catalogue Number: 0166L16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 07/09/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1