FDA Adverse Event
Malfunction
Summary report: N
POWERPICC
MDR report key: 25019796
·
Received April 28, 2026
Report
- Report Number
- 3006260740-2026-02960
- Event Type
- Malfunction
- Date Received
- April 28, 2026
- Date of Event
- April 8, 2026
- Report Date
- April 15, 2026
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- UDI-DI
- 00801741034466
- PMA / PMN Number
- K091324
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT HAD THE PICC SINCE (B)(6) 2025 AND GETTING MEDICATION AT HOME AND NOTICED THE PICC WAS LEAKING WHEN FLUSHING. PT WENT TO THE ER REMOVED THE PICC AND REPLACED WITH ANOTHER PICC. IT WAS BROKEN AT THE 9CM MARK WHEN REMOVED. NO SECUREMENT DEVICE, ONLY TEGADERM IV ADVANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192512 | POWERPICC | PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REKQ3093 | 00801741034466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |