FDA Adverse Event
Malfunction
Summary report: N
PSI KIT: 8.5 FR X 4 (10 CM)
MDR report key: 2150545
·
Received June 22, 2011
Report
- Report Number
- 1036844-2011-00195
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 29, 2011
- Report Date
- June 16, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- KGZ
- PMA / PMN Number
- K781846
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE CATHETER WAS PLACED IN THE PT'S INTERNAL JUGULAR THEY ATTEMPTED TO WITHDRAW BLOOD; THEY NOTICED BUBBLES. AS A RESULT, THE CATHETER WAS EXCHANGED FOR A NEW ONE. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PSI KIT: 8.5 FR X 4 (10 CM) | CRITICAL CARE PSI PRODUCTS | KGZ | ARROW INTL., INC. | RF1033551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |