FDA Adverse Event
Malfunction
Summary report: N
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
MDR report key: 12776348
·
Received November 8, 2021
Report
- Report Number
- 0001625425-2021-01116
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- September 30, 2021
- Report Date
- November 23, 2021
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- LJS
- UDI-DI
- 00886333209934
- PMA / PMN Number
- K091670
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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.
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
CRACKING AT THE HUB.
Description of Event or Problem · 0
CRACKING AT THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1663145 | L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM | L-CATH PICC | LJS | ARGON MEDICAL DEVICES | 384539 | UNK | 00886333209934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |