MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-03-18 for COPAN FLOQSWAB 518CS01 manufactured by Copan Flock Technologies Srl.
[20291756]
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.
Patient Sequence No: 1, Text Type: D, B5
[20496450]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005477219-2014-00002 |
| MDR Report Key | 3708242 |
| Report Source | 05,08 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-02-15 |
| Date Mfgr Received | 2014-02-24 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2014-03-31 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2014-03-18 |
| Model Number | 518CS01 |
| Catalog Number | 518CS01 |
| Lot Number | 5E3800 |
| Device Expiration Date | 2014-10-31 |
| 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 | 2014-03-18 |