FDA Adverse Event
Other
Summary report: N
CATH PICC
MDR report key: 2189689
·
Received July 25, 2011
Report
- Report Number
- 2925153-2011-00010
- Event Type
- Other
- Date Received
- July 25, 2011
- Date of Event
- June 13, 2011
- Report Date
- July 19, 2011
- Manufacturer
- NEO MEDICAL INC
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6) WILL PROVIDE F/U REPORT AS NOTED BELOW: F/U WILL BE PROVIDED WHEN "DEVICE EVAL SUMMARY IS COMPLETED". (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, COMPLAINT COORD RECEIVED A FAXED REPORT THAT STATED "LEAK WAS DISCOVERED RIGHT AWAY IN PICC LINE, NO CONSEQUENCES TO THE PT". (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CATH PICC | V-CATH PICC SELINGER SINGLE LUMEN | LJS | NEO MEDICAL INC | 4068-1660 | 1036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |