FDA Adverse Event
Malfunction
Summary report: N
PSI KIT: 8.5 FR
MDR report key: 2505782
·
Received March 22, 2012
Report
- Report Number
- 3006425876-2012-00023
- Event Type
- Malfunction
- Date Received
- March 22, 2012
- Date of Event
- February 2, 2012
- Report Date
- March 20, 2012
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- KGZ
- PMA / PMN Number
- K780532
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A MALE PT IN THE (B)(4). THE CATHETER WAS PLACED INTO THE PT'S INTERNAL JUGULAR. DURING POST OP CARE THE CLINICIAN NOTICED LEAKAGE AROUND THE 7FR SWAN GANZ CATHETER OVERNIGHT. IT WAS NOTED THAT BOTH THE INTRODUCER AND CATHETER WERE THEN REMOVED AND DISCONTINUED USE. NO ADVERSE ACTION WAS CAUSED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS OKAY. ON (B)(6) 2012 - FOLLOW UP INFO CONFIRMS THEY ALWAYS USES A 7FR CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PSI KIT: 8.5 FR | CRITICAL CARE PSI PRODUCTS | KGZ | ARROW INTERNATIONAL INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |