FDA Adverse Event
Injury
Summary report: N
BARD TL CVC CATHETER
MDR report key: 15792916
·
Received November 14, 2022
Report
- Report Number
- 3006260740-2022-05170
- Event Type
- Injury
- Date Received
- November 14, 2022
- Date of Event
- November 22, 2021
- Report Date
- September 9, 2022
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 0
IT WAS REPORTED DURING CLINICAL ASSESSMENT. THERE IS REDNESS, SWELLING AND/OR FLUID DRAINAGE AT THE INSERTION SITE. THIS EVENT INVOLVED 1 TL CVC INSERTED SUBCLAVIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2767885 | BARD TL CVC CATHETER | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |