FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 4 FR X 8 CM
MDR report key: 19298602
·
Received May 13, 2024
Report
- Report Number
- 3006425876-2024-00460
- Event Type
- Malfunction
- Date Received
- May 13, 2024
- Date of Event
- March 13, 2024
- Report Date
- April 17, 2024
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- UDI-DI
- 10801902099645
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
QN# (B)(4). "NEW INFORMATION RECEIVED INDICATES THAT THIS WAS NOT A REPORTABLE EVENT, THUS, THE INITIAL MDR SUBMITTED ON 13/05/2024 SHOULD BE RE TRACTED."
Additional Manufacturer Narrative · 0
QN# (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT: "(B)(6) 2024, THE CATHETER TIP WAS FOUND DEFORMED DURING USE ON THE PATIENT. THE PATIENT WAS REPROTED AS FINE.
Description of Event or Problem · 0
IT WAS REPORTED THAT: "(B)(6) 2024, THE CATHETER TIP WAS FOUND DEFORMED DURING USE ON THE PATIENT. THE PATIENT WAS REPROTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841243 | CVC SET: 2-LUMEN 4 FR X 8 CM | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | 71F23H0257 | 10801902099645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED.| NOT REPORTED. |