FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 7 FR X 6IN (16 C M)PSI KIT: 9 FR
MDR report key: 2102953
·
Received May 4, 2011
Report
- Report Number
- 2242445-2011-00055
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 27, 2011
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- FOZ
- PMA / PMN Number
- K993691
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE CENTRAL VENOUS CATHETER (CVC) WAS PLACED FOR THE PT AND THEY CONNECTED THE IV TUBING, THE TUBING WAS THEN FLUSHED WITH HEPARINIZED SALINE SOLUTION. A LEAK WAS OBSERVED AT THE STOPCOCK. THEY FEEL THE LEAK WAS COMING FROM THE SEAM WHERE IT IS BONDED TOGETHER. AS A RESULT, THE CLINICIAN REPLACED THE STOPCOCK WITH A NEW ONE FROM THEIR INVENTORY. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT'S OUTCOME WAS NORMAL. REFERENCE MDR #2242445-2011-00056 FOR THE SECOND EVENT INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC KIT: 7 FR X 6IN (16 C M)PSI KIT: 9 FR | ARROWG+ARD CATHETER PRODUCTS | FOZ | ARROW INTERNATIONAL INC | MF0126837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |