MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.

Catalog Number 175816

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the catheter would not drain so the staff allegedly had to manipulate the catheter.After the catheter was manipulated, 1200-1300 ml of urine reportedly drained.

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 states the following: "caution: do not aspirate urine through drainage funnel wall.Visually inspect the product for any imperfections or surface deterioration prior to use.Single patient use only.Do not reuse.Do not resterilize." 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.

Event Description

It was reported that the catheter would not drain so the staff allegedly had to manipulate the catheter.After the catheter was manipulated, 1200-1300 ml of urine reportedly drained.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6505098
• MDR Text Key: 73379098
• Report Number: 1018233-2017-01904
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 175816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1