FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 16 GA X 12
MDR report key: 2002520
·
Received January 28, 2011
Report
- Report Number
- 9680794-2011-00004
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 27, 2011
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K820009
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 THAT TWO WEEKS AFTER THE CATHETER WAS INDWELLED, A LEAK WAS OBSERVED FROM THE JUNCTURE HUB WHILE IN THE HOSPITAL WARD. AS A RESULT, THE CATHETER WAS REMOVED BUT IT IS UNKNOWN WHY IT WAS NOT REPLACED. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011, FROM (B)(6) INDICATED ANOTHER CATHETER WAS REINSERTED SUCCESSFULLY FOLLOWING THE DIFFICULTY WITH THE FIRST CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC SET: 16 GA X 12 | SINGLE LUMEN CVC PRODUCTS | DQY | ARROW INTERNATIONAL INC. | CF0091661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |