FDA Adverse Event
Malfunction
Summary report: N
BD L-CATH PICC DUAL LUMEN CATHETER
MDR report key: 2030813
·
Received March 22, 2011
Report
- Report Number
- 1625425-2011-00026
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- January 25, 2011
- Report Date
- March 22, 2011
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- DQX
- PMA / PMN Number
- K925979
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PT BECAME AGITATED WITH TACHYCARDIA, HYPERTENSION, AND FEVER. LATER, A LEAKING PICC WAS DISCOVERED, WHICH HAD ALLOWED LOSS OF SEDATION MEDICATION, POSSIBLY ALLOWING PT TO ENTER WITHDRAWAL. PICC LINE WAS REPLACED WITH SINGLE LUMEN CATHETER FOR REMAINDER OF THERAPY. THIS MODEL PICC LINE HAS BEEN OBSERVED TO LEAK SEVERAL TIMES WITHIN THE PAST YEAR. THE STAFF BELIEVES CATHETER WILL OFTEN LEAK AFTER TWO WEEKS OF USE, BUT THIS ONE DEVELOPED A LEAK AFTER ONLY TWENTY FOUR HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD L-CATH PICC DUAL LUMEN CATHETER | DQX | ARGON MEDICAL DEVICES | NA | 0027376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Other |