FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 14 FR X 25 CM
MDR report key: 3101392
·
Received May 3, 2013
Report
- Report Number
- 3006425876-2013-00088
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- March 7, 2013
- Report Date
- May 2, 2013
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- MPB
- PMA / PMN Number
- K993933
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S LEFT JUGULAR IN THE INTENSIVE CARE UNIT. DURING INSERTION, THE SPRING WIRE GUIDE UNRAVELED. AS A RESULT, THE CATHETER AND WIRE WERE REMOVED AS ONE AND ANOTHER CATHETER WAS PLACED INTO THE PATIENT'S RIGHT JUGULAR. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194633 | CVC SET: 2-LUMEN 14 FR X 25 CM | ARROWG+ARD AND CATHETER PRODUCTS | MPB | ARROW INTERNATIONAL INC. | ZF2086775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |