FDA Adverse Event
Malfunction
Summary report: N
L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
MDR report key: 12782632
·
Received November 9, 2021
Report
- Report Number
- 0001625425-2021-01118
- Event Type
- Malfunction
- Date Received
- November 9, 2021
- Report Date
- December 13, 2021
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- LJS
- UDI-DI
- 00886333209910
- PMA / PMN Number
- K091670
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SEVERAL COMPLAINTS HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE, AND CAPA 2021-039 HAS BEEN INITIATED TO ADDRESS THIS ISSUE AND IS CURRENTLY UNDER INVESTIGATION. THE CAPA WILL IDENTIFY THE SPECIFIC CAUSES AND CORRECTIVE ACTIONS TO BE TAKEN.
Additional Manufacturer Narrative · 0
THE DEVICE IS INDICATED AS AVAILABLE FOR RETURN, AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED.
Description of Event or Problem · 0
PICC CRACKED @ HUB AND ALSO @ BLUE HUB.
Description of Event or Problem · 0
PICC CRACKED @ HUB AND ALSO @ BLUE HUB¿.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674694 | L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN) | L-CATH PICC | LJS | ARGON MEDICAL DEVICES | 384516 | UNK | 00886333209910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |