FDA Adverse Event Malfunction Summary report: N

POWERPICC

MDR report key: 24621873 · Received March 17, 2026

Report

Report Number
3006260740-2026-01673
Event Type
Malfunction
Date Received
March 17, 2026
Date of Event
March 3, 2026
Report Date
March 6, 2026
Manufacturer
C.R. BARD, INC. (BASD) -3006260740
Product Code
LJS
UDI-DI
00801741139017
PMA / PMN Number
UNKNOWN
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FI
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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem · 0

IT WAS REPORTED DURING INSERTION PLACER NOTICED, THAT NITINOL GUIDEWIRE WAS BLACK AND ALSO STIFFER THAN IT USED TO BE. NO HARM TO PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
684028 POWERPICC PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741139017

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other