FDA Adverse Event
Other
Summary report: N
MICROCLAVE CONNECTOR
MDR report key: 1732097
·
Received June 10, 2010
Report
- Report Number
- 2025816-2010-00057
- Event Type
- Other
- Date Received
- June 10, 2010
- Date of Event
- April 18, 2010
- Report Date
- April 21, 2010
- Manufacturer
- ICU MEDICAL INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
FDA/(B)(4) REPORT REC'D. REPORTING AN INCIDENT INVOLVING ONE (1) 12568 MICROCLAVE CONNECTOR. THE REPORT STATES THE "END CAP FAILED TO RETURN TO FLUSH STATE AFTER BEING FLUSHED." THERE WERE NO ADVERSE PT CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE INVOLVED 12568 MICROCLAVE DEVICE AND CONCOMITANT MATING/ACCESS DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT# 86-672-SN (MFG. DATE 02/2010) SHOWS (B)(4) UNITS WERE MANUFACTURED., TESTED, INSPECTED, AND RELEASED. EXACT CAUSE(S) OF THE EVENT ARE UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROCLAVE CONNECTOR | CONNECTOR | FPA | ICU MEDICAL INC. | 12568 | 86-672-SN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | MFR. MAKE & MODEL UNKNOWN| IV TUBING SET| MATING/ACCESS DEVICES |