FDA Adverse Event
Malfunction
Summary report: N
SHERLOCK 3CG+ DISPLAY ROW
MDR report key: 20251890
·
Received September 18, 2024
Report
- Report Number
- 3006260740-2024-05265
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Date of Event
- August 23, 2024
- Report Date
- September 6, 2024
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- PMA / PMN Number
- K180560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING BEDSIDE PICC PLACEMENT, DESPITE THE P WAVE AND MAGNET BEING GREEN (+ MAGNET DEFORMED INTO A DIAMOND), THE PICC TIP, END POINT WAS CONFIRMED TO BE LOCATED IN THE RIGHT ATRIUM AND TRACHEAL BIFURCATION, NOT IN THE CAJ. (CONFIRMATION BY ECHOCARDIOGRAPHY, CT, AND X-RAY). NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2526619 | SHERLOCK 3CG+ DISPLAY ROW | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |