FDA Adverse Event
Malfunction
Summary report: N
NANOCLAVE CONNECTOR
MDR report key: 9687951
·
Received February 10, 2020
Report
- Report Number
- 9617594-2020-00044
- Event Type
- Malfunction
- Date Received
- February 10, 2020
- Date of Event
- January 1, 2020
- Report Date
- January 24, 2020
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- FPA
- UDI-DI
- 00840619060909
- PMA / PMN Number
- K100434
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
H10: A USED DEVICE WAS NOT RETURNED FOR EVALUATION. A DHR (DEVICE HISTORY REVIEW) LOT# 3970567 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION FOUND IN D10.
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO RETURN TO THE MANUFACTURER FOR INVESTIGATION; IT HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
THE DATE OF THE EVENT IS UNKNOWN. THE EVENT INVOLVED A NANOCLAVE¿ CONNECTOR THAT DID NOT ALLOW FLOW WHEN THE ANESTHETIST ATTEMPTED TO INJECT EMERGENCY MEDICATIONS THROUGH THE CONNECTOR. THE CUSTOMER STATED IT WAS NEAR IMPOSSIBLE TO INJECT, EVEN WITH PRESSURE. THIS REPORT CAPTURES THE SECOND OF TWO INCIDENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151865 | NANOCLAVE CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | 3970567 | 00840619060909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |