MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD LUBIRI-SIL TEMP-SENSING MOLEX

Catalog Number 119216M

Device Problem Balloon mushroomed (1053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that there was a cuff roll noted on the catheter when it was returned.

Manufacturer Narrative

The sample was returned for eval.The device history record was reviewed for the reported lot number and found nothing that could have caused or contributed to the reported event.The finished product met all specs prior to being released for general distribution.An attributed of all-silicone catheters is that they may not recover their original shape after balloon inflation.This can be exacerbated by rapid deflation, over inflation and extended indwelling time.(b)(4).

• Brand Name: LUBIRI-SIL TEMP-SENSING MOLEX
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km 7 carretera internacional; nogales, sonora ; MX
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4219091
• MDR Text Key: 21526759
• Report Number: 1018233-2014-00201
• Device Sequence Number: 1
• Product Code: EZL
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 119216M
• Device Lot Number: NGYA2461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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