FDA Adverse Event
Malfunction
Summary report: N
PI PICC KIT: 2-L 5 FR X 50 CM WITH PRELO
MDR report key: 3955852
·
Received June 25, 2014
Report
- Report Number
- 1036844-2014-00283
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 23, 2014
- Manufacturer
- ARROW INTL., INC.
- Product Code
- LJS
- PMA / PMN Number
- K121941
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S ARM. ACCORDING TO THE CLINICIAN, THE PT'S SKIN WASN'T ALL THAT TOUGH TO GO THROUGH. NO SKIN NICK WAS MADE. DURING INSERTION, THE GLIDE THRU SHEATH "CURLED" BACK WHEN TRYING TO PUSH THROUGH THE PT'S SKIN. AS A RESULT, ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369845 | PI PICC KIT: 2-L 5 FR X 50 CM WITH PRELO | PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | ARROW INTL., INC. | 23F14C0463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |