MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-02-07 for COPAN FLOQSWAB 518CS01 manufactured by Copan Flock Technologies Srl.
[19587654]
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 Sequence No: 1, Text Type: D, B5
[19825331]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005477219-2014-00001 |
| MDR Report Key | 3645059 |
| Report Source | 05,08 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-02-07 |
| Date of Event | 2013-12-15 |
| Date Mfgr Received | 2014-01-09 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 302687212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPAN FLOQSWAB |
| Product Code | KXG |
| Date Received | 2014-02-07 |
| Model Number | 518CS01 |
| Catalog Number | 518CS01 |
| Lot Number | 4C0I00 |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Address | VIA F. PEROTTI 16-18 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-07 |