FDA Adverse Event
Malfunction
Summary report: N
ARTERIAL CATH SET:20GA C ATH/22GA NDL
MDR report key: 2033919
·
Received February 11, 2011
Report
- Report Number
- 1036844-2011-00050
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 26, 2011
- Report Date
- February 7, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, 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 THE CATHETER WAS PLACED IN THE PT. POST INSERTION, BLEEDING WAS NOTICED AT THE INSERTION SITE AND THE DRESSING WAS REMOVED. THEY DISCOVERED A CRACK IN THE CATHETER PORT OF THE LINE. AS A RESULT, IT WAS REMOVED WITHOUT INCIDENT AND WAS DISCONTINUED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. NO PT INJURY WAS REPORTED. REFERENCE MDR #1036844-2011-00051 FOR THE SECOND EVENT INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTERIAL CATH SET:20GA C ATH/22GA NDL | ARTERIAL CATHETER PRODUCTS | DQX | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |