FDA Adverse Event
Malfunction
Summary report: N
L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM
MDR report key: 12228326
·
Received July 27, 2021
Report
- Report Number
- 0001625425-2021-01044
- Event Type
- Malfunction
- Date Received
- July 27, 2021
- Date of Event
- July 9, 2021
- Report Date
- August 27, 2021
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- LJS
- PMA / PMN Number
- K091670
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE RETURNED CATHETER FOUND A CRACKED HUB WHICH WOULD RESULT IN LEAKAGE, CONFIRMING THE COMPLAINT. CAPA C-2020-016 WAS PREVIOUSLY INITIATED TO ADDRESS THE PROBLEM, HOWEVER, THE CORRECTIVE ACTIONS IMPLEMENTED FAILED TO MITIGATE THE FAILURE. THE ROOT CAUSE INVESTIGATION HAS BEEN RE-OPENED WITH A NEW CAPA C-2021-039. THE CAPA WILL ALSO CAPTURE THE INITIATIVE TO IMPROVE THE PRODUCT DESIGN.
Description of Event or Problem · 0
PICC CRACKED. PRODUCT HAD TO BE REPLACED.
Additional Manufacturer Narrative · 1
THE SAMPLE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE SAMPLE HAS BEEN RECEIVED AND REVIEWED.
Description of Event or Problem · 1
PICC CRACKED. PRODUCT HAD TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1123311 | L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM | L-CATH PICC | LJS | ARGON MEDICAL DEVICES | 384466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |