MAUDE Adverse Event Report: COPAN FLOCK TECHNOLOGIES SRL COPAN FLOQSWAB

Model Number 518CS01

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2014

Event Type  Injury  

Event Description

The event description provided by the hosp indicates that a pt was swabbed via left nare for h1n1 (influenza swab) specimen collection.As the registered nurse pulled the swab out, she noticed that the distal tip of swab at thin joint wasn't attached (had broken off) and remained in the pt's nares.The rn conducted a thorough search of the pt's room to see if she could locate the broken piece to no avail.One physician attempted visualization, but was unable to visualize the product.One of er physicians attempted to retrieve the piece of swab, but was unable to locate the piece.At the time of the event, pt already had an et tube for ventilation.On (b)(6) 2014, a bronchoscopy was performed and the broken piece was successfully found and removed.Note: the pt was sedated as part of his ventilator care.There are no adverse effects on the pt as a result of this event.

Manufacturer Narrative

Analysis of device history records: copan checked the internal records related to the controls made on the code 518cs01, lot number 5e3800 before the market release.No anomalies have been found: lot reported in the incident met mfg specs.The original lot, manufactured in 2011, was comprised of (b)(4) units, this is the first notification received for this specific lot.The device was not returned to copan for eval.Mechanical test on the returned to copan for eval.Mechanical test on the retained sample from the claimed lot has been performed: all the tested swabs gave conform results.We are unable to determine a root cause for the reported event.Our investigation could not confirm any malfunction or defect in the device lot associated with this incident.Info from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend info is used to identify the need for add'l investigations.

• Brand Name: COPAN FLOQSWAB
• Manufacturer (Section D): COPAN FLOCK TECHNOLOGIES SRL; via f perotti 16-18; brescia 2512 5; IT 25125
• Manufacturer Contact: via f perotti 16-18; brescia 25125 ; 302687212
• MDR Report Key: 3708242
• MDR Text Key: 20291756
• Report Number: 3005477219-2014-00002
• Device Sequence Number: 1
• Product Code: KXG
• 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,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: 518CS01
• Device Catalogue Number: 518CS01
• Device Lot Number: 5E3800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR