| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COPAN FLOQSWAB | COPAN FLOCK TECHNOLOGIES SRL | KXG | 518CS01 | 518CS01 | 4C0I00 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-02-07 | 0 | 1. R |
Patient 1
THE EVENT OCCURRED IN (B)(6), AND HAS BEEN REPORTED TO THE (B)(6) AUTHORITY. THE EVENT DESCRIPTION PROVIDED BY THE LOCAL DISTRIBUTOR REFERS OF A SWAB THAT BROKE OFF AT THE TRANSITION POINT WHERE THE SHAFT CHANGES FROM THIN TO THICK DIAMETER DURING NASOPHARYNGEAL SAMPLING. THE PATIENT WAS PROBABLY SEDATE. A NASAL FIBROSCOPY WAS APPLIED IN ORDER TO REMOVE THE PART OF THE SWAB OUT OF PATIENT'S NOSE. THIS INTERVENTION LED TO A SLIGHTLY BLEEDING OF THE NOSE.
Patient 1
ANALYSIS OF DEVICE HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 518CS01, LOT NUMBER 4C0I00 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND: LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE ORIGINAL LOT, MANUFACTURED IN 2011, WAS COMPRISED OF 5000 UNITS, THIS IS THE FIRST NOTIFICATION RECEIVED FOR THIS SPECIFIC LOT. THE DEVICE WAS NOT RETURNED TO COPAN FOR EVALUATION. 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. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.