MAUDE Adverse Event Report: COOPERSURGICAL, INC. INCA COMPLETE SET, SIZE 15F; INFANT NASAL CPAP ASSEMBLY

Model Number 44-2715

Device Problem Device Slipped (1584)

Patient Problem Pneumothorax (2012)

Event Date 12/03/2013

Event Type  malfunction  

Event Description

The distributor reported that the tubing was slipping off at both ends of the cannula.The end user reported that a pneumothorax occurred, but is not 100% certain if this device related.

Manufacturer Narrative

The inca 15f has not been returned yet to coopersurgical for evaluation.This complaint is currently still under investigation by out quality engineering dept.(b)(4).

• Brand Name: INCA COMPLETE SET, SIZE 15F
• Type of Device: INFANT NASAL CPAP ASSEMBLY
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 3647400
• MDR Text Key: 4280535
• Report Number: 1216677-2013-00040
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/02/2014

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: 12/31/2015
• Device Model Number: 44-2715
• Device Lot Number: 137873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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