MAUDE Adverse Event Report: PRODUCTOS PARA EL CIUDADO DE LA SALUD LUBRISIL IC TEMP SENSING FOLEY

Catalog Number 119312M

Device Problem Mushroomed (2987)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the temp sensing foley catheter was not registering the temperature.Further investigation of the sample was received, a cuff roll was found.

Manufacturer Narrative

Received 1 used silicone temp-sensing foley catheter.Visual inspection noted that the temperature wire appears to have "snaked" inside the catheter.Further inspection noted a cuff roll on the balloon.Per functional evaluation, a cuff roll was formed after deflation.Dimensional evaluation found the catheter length to be within specification.The reported event was confirmed with the cause unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.(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.

• Brand Name: LUBRISIL IC TEMP SENSING FOLEY
• Manufacturer (Section D): PRODUCTOS PARA EL CIUDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CIUDADO DE LA SALUD; km.7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4912033
• MDR Text Key: 6027492
• Report Number: 1018233-2015-00220
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

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 Expiration Date: 07/31/2019
• Device Catalogue Number: 119312M
• Device Lot Number: NGYF2168
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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