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

Model Number	0167L22
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 catheter could not be irrigated.The catheter was replaced without further incident.No patient injury was reported.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection found no irrigation eye on the catheter.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿ visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that the catheter could not be irrigated.The catheter was replaced without further incident.No patient injury was reported.

• 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: 6526218
• Report Number: 1018233-2017-02131
• Device Sequence Number: 13509399
• Product Code: KOD
• UDI-Device Identifier: 00801741018978
• UDI-Public: (01)00801741018978(10)NGAY1564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/02/2017

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 Expiration Date: 05/31/2021
• Device Model Number: 0167L22
• Device Catalogue Number: 0167L22
• Device Lot Number: MA6285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization