MAUDE Adverse Event Report: EXCELSIOR MEDICAL LUER ACCESS CAP POUCH; LUER CAP

Model Number CV9025

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

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

Event Type  Injury  

Manufacturer Narrative

There were no samples received with this complaint; therefore, an examination of the issue could not be made.A review of the device history record was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, a date of manufacture could not be determined.The supplier performed an investigation.The swabcap device is designed by prevent accidental removal with requirements for minimum axial removal force and removal torque.However, as with any catheter related products that are torqued on, there is an inherent risk that the component could be accidentally disconnected or improperly connected.As a result, the instructions for use (ifu) for the swabcap products directs the end users to verify the swabcap has been twisted firmly onto the device and that the luer access valve is securely in place.Without further information, a root cause could not be determined.A potential root cause could be that the connection was not verified to be twisted firmly onto the device and that the luer access valve was not securely in place.Corrective action will be taken out of an abundance of caution to update the device ifu for a potential choking hazard.This complaint will be considered confirmed.If additional information or samples are received, the investigation will resume as needed.This complaint will be used for trending and tracking purposes.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a luer cap.The customer stated that a pediatric patient was chewing on an iv line and the swabcap came off the line.The patient swallowed the cap and had to have the heimlich maneuver performed to dislodge the cap.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

• Brand Name: LUER ACCESS CAP POUCH
• Type of Device: LUER CAP
• Manufacturer (Section D): EXCELSIOR MEDICAL; 1933 heck avenue; neptune NJ 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4413393
• MDR Text Key: 13433458
• Report Number: 1282497-2015-00005
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CV9025
• Device Catalogue Number: CV9025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other