FDA Adverse Event
Malfunction
Summary report: N
NEOMAGIC
MDR report key: 20075118
·
Received August 27, 2024
Report
- Report Number
- 20075118
- Event Type
- Malfunction
- Date Received
- August 27, 2024
- Date of Event
- July 12, 2024
- Report Date
- July 23, 2024
- Manufacturer
- NEO MEDICAL INC.
- Product Code
- KZH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
I WAS PLACING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) USING THE NEOMAGIC MODIFIED SELDINGER INTRODUCER KIT (1.9/2.0 FR 30GA MODIFIED SELDINGER INTRODUCER KIT, LOT #1066), AND WHEN I WENT TO PEEL AWAY THE BLUE INTRODUCER, ONE BLUE WING CAME OFF AT THE VERY START BEFORE TEARING THE REMAINDER OF CATHETER APART. I WAS ABLE TO USE MY TWEEZERS AND PEEL APART THE REST OF THE CATHETER. MANUFACTURER RESPONSE FOR INTRODUCER, SYRINGE NEEDLE, NEOMAGIC (PER SITE REPORTER) THEY OFFERED AN RMA WITH INSTRUCTIONS ON RETURNING SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23590 | NEOMAGIC | INTRODUCER, SYRINGE NEEDLE | KZH | NEO MEDICAL INC. | 1958-004 | 1066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 DA | Female |