FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 14 GA X 20 CM
MDR report key: 3190556
·
Received June 21, 2013
Report
- Report Number
- 3006425876-2013-00112
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 28, 2013
- Report Date
- June 20, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K820009
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
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 CLINICIAN STATED THE PUNCTURE NEEDLE GOT BROKEN. A NEW SET WAS USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283561 | CVC KIT: 14 GA X 20 CM | SINGLE LUMEN CVC PRODUCTS | DQY | ARROW INTERNATIONAL INC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |