FDA Adverse Event
Malfunction
Summary report: N
POWERPICC 4F SL MAX BARRIER PLUS KIT W/BIOPATCH & PC
MDR report key: 12206898
·
Received July 21, 2021
Report
- Report Number
- 3006260740-2021-02875
- Event Type
- Malfunction
- Date Received
- July 21, 2021
- Date of Event
- June 19, 2021
- Report Date
- June 30, 2021
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- UDI-DI
- 00801741155048
- PMA / PMN Number
- K070996
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFP1999 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REFP1999) HAVE BEEN REPORTED FROM THE SAME FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED 6/19 @ 1040 RIGHT BASILIC 4FR SINGLE LUMEN PICC PLACED. TRIMMED AT 45CM, CIRCUMFERENCE 39CM. WE HAD A GOOD P-WAVE BUT X-RAY SHOWED SHORT. AN OVER THE GUIDEWIRE WAS COMPLETED SINCE THE PATIENT'S OTHER SIDE CANNOT BE USED WITH NO COMPLICATIONS. ADDITIONAL INFO. RCVD 06/22/2021: WAS THERE ANY PATIENT HARM REPORTED? - NO, AN OVER THE GUIDEWIRE EXCHANGE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1101008 | POWERPICC 4F SL MAX BARRIER PLUS KIT W/BIOPATCH & PC | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REFP1999 | 00801741155048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |