MAUDE Adverse Event Report: COVIDIEN SHILEY; DISPOSABLE CANNULA LOW PRESSURE CUF

Catalog Number 4DCT

Device Problem Misconnection (1399)

Patient Problem Respiratory Distress (2045)

Event Date 10/28/2013

Event Type  Injury  

Event Description

Customer reported an iv line was attached to a luer lock that was attached to the pilot balloon line.The pt went into respiratory distress.Customer believes that product labeling should advise against use of product with a luer lock.Covidien has attempted to gather further details surrounding the circumstances of this report, however, we have not received any additional information.

Manufacturer Narrative

(b)(4).The lot number 1380078jzx is not a valid lot number; therefore, the mfr date is not available.We are unable to determine the exact cause for this specific event however, manufacturing controls are in place to detect related issues and to reduce the potential for occurrence during the manufacturing process.Information of this nature is included in our database and monitoring through trending.

• Brand Name: SHILEY
• Type of Device: DISPOSABLE CANNULA LOW PRESSURE CUF
• Manufacturer (Section D): COVIDIEN; avenida henequen; cd juarez; chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarex ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 3697619
• MDR Text Key: 4266804
• Report Number: 2936999-2014-00194
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4DCT
• Device Lot Number: 1380078JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention