L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
Report
- Report Number
- 0001625425-2021-01113
- Event Type
- Malfunction
- Date Received
- November 2, 2021
- Date of Event
- September 30, 2021
- Report Date
- November 22, 2021
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- LJS
- UDI-DI
- 00886333209910
- PMA / PMN Number
- K091670
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EXACT ROOT CAUSE FOR THE CRACKED HUBS COULD NOT BE ESTABLISHED WITH CONFIDENCE. MULTIPLE COMPLAINTS HAVE BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE THRU THE CRACKED HUB. CAPA C-2020-016 WAS INITIATED TO ADDRESS THIS ISSUE, BUT THIS CAPA FAILED ON EFFECTIVENESS STAGE. CAPA C 2021-039 WAS INITIATED TO FURTHER ADDRESS THIS ISSUE. CAPA C-2021-039 WAS INITIATED TO ADDRESS THE CRACKED HUB ISSUE AND IS CURRENTLY IN THE ROOT CAUSE INVESTIGATION STAGE. THE CAPA WILL IDENTIFY THE ROOT CAUSES AND CORRECTIVE ACTIONS AS DATA IS COMPILED.
THE DEVICE WAS RETURNED, AND EVALUATION IS ANTICIPATED BUT HAD NOT YET BEGUN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN EVALUATED.
DATE OF INSERTION; (B)(6) 2021. DATE LEAKING LINE/CRACK NOTED IN CATHETER; (B)(6) 2021. LOT # 11370011. IN THIS CASE THE CATHETER WAS SUCCESSFULLY REMOVED AND ANOTHER PICC CATHETER HAD TO BE INSERTED.
DATE OF INSERTION; (B)(6) 2021. DATE LEAKING LINE/CRACK NOTED IN CATHETER; (B)(6) 2021. LOT # 11370011. IN THIS CASE THE CATHETER WAS SUCCESSFULLY REMOVED AND ANOTHER PICC CATHETER HAD TO BE INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1632604 | L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN) | L-CATH PICC | LJS | ARGON MEDICAL DEVICES | 384516 | 00886333209910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |