MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 30CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH; SILICONE CATHETER

Catalog Number	166818
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
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 catheters allegedly had blocked lumens, although they were irrigated frequently.The catheter was replaced.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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 catheters allegedly had blocked lumens, although they were irrigated frequently.The catheter was replaced.

• Brand Name: BARDEX 2-WAY 30CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6491006
• Report Number: 1018233-2017-01809
• Device Sequence Number: 19081346
• Product Code: EZL
• UDI-Device Identifier: 00801741029813
• UDI-Public: (01)00801741029813(10)NGAV5006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

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: 07/31/2021
• Device Catalogue Number: 166818
• Device Lot Number: NGAV5006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1