FDA Adverse Event
Malfunction
Summary report: N
ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS
MDR report key: 8168786
·
Received December 17, 2018
Report
- Report Number
- 1036844-2018-00317
- Event Type
- Malfunction
- Date Received
- December 17, 2018
- Date of Event
- December 7, 2018
- Report Date
- December 7, 2018
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem · 0
THE CUSTOMER REPORTS THE PEEL AWAY SHEATH BROKE DURING REMOVAL. THE ENTIRE SHEATH WAS REMOVED.
Additional Manufacturer Narrative · 1
QN# (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTS THE PEEL AWAY SHEATH BROKE DURING REMOVAL. THE ENTIRE SHEATH WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1009819 | ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS | CATHETER, INTRODUCER | DYB | ARROW INTERNATIONAL INC. | TBD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |