FDA Adverse Event
Malfunction
Summary report: N
EPICUTANEO-CAVE CATHETER
MDR report key: 2063957
·
Received March 23, 2011
Report
- Report Number
- 2245270-2011-00015
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- October 15, 2010
- Report Date
- March 23, 2011
- Manufacturer
- VYGON GMBH
- Product Code
- LJS
- PMA / PMN Number
- K897168
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE WAS SENT TO VYGON (B)(4) FOR INVESTIGATION. RESULTS OF THIS INVESTIGATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP MDR. ADD'L LOT# 040684.
Description of Event or Problem · 1
WITHIN 48 HOURS OF BEING PLACED IN PRETERM AND TERM INFANTS, A FEW OCCURRENCES OCCURRED WHERE CATHETERS SPLIT RIGHT BEFORE THE HUB. WHEN ATTEMPTING TO REPAIR THE CATHETER, SPLITTING WOULD RECUR, REQUIRING COMPLETE CHANGE OF THE PICC. TPN AND LIPIDS WERE BEING ADMINISTERED EITHER BY PUMP OR SYRINGE. THE 5ML OR 10ML SYRINGES WERE USED FOR ADMINISTERING OF FLUIDS AND/OR FLUSHING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPICUTANEO-CAVE CATHETER | CATHERER, INTRAVASCULAR, LONG TERM (PICC) | LJS | VYGON GMBH | 2184.00 | 036747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |