FDA Adverse Event
Malfunction
Summary report: N
NAVILYST MEDICAL/VAXCEL PASV PICC
MDR report key: 1162845
·
Received September 9, 2008
Report
- Report Number
- 1317056-2008-00065
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 14, 2008
- Manufacturer
- NAAVILYST MEDICAL
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. NO PREVIOUS COMPLAINTS HAVE BEEN RECEIVED ON THE REPORTED LOT NUMBER. ALTHOUGH THE USED DEVICE HAS BEEN RETURNED, THE DEVICE EVALUATION IS STILL ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
AS REPORTED, DURING PREP, THE PICC TEAM NOTED THAT THERE WAS A HOLE IN THE CATHETER JUST DISTAL TO THE SUTURE WING. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS BEING RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVILYST MEDICAL/VAXCEL PASV PICC | VALVED PICC DEVICE | LJS | NAAVILYST MEDICAL | N/A | 1263718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |