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