FDA Adverse Event Malfunction Summary report: N

BARD PICC

MDR report key: 18138941 · Received November 15, 2023

Report

Report Number
3006260740-2023-05181
Event Type
Malfunction
Date Received
November 15, 2023
Date of Event
October 26, 2023
Report Date
January 9, 2024
Manufacturer
C.R. BARD, INC. (BASD) -3006260740
Product Code
LJS
PMA / PMN Number
UNK
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
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 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 RECEIVED BY THE MANUFACTURER FOR EVALUATION.

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.

Description of Event or Problem · 0

IT WAS REPORTED BY CUSTOMER THAT PICC LINE GETTING COILED AFTER CT (PHI). NO OTHER INFORMATION WAS PROVIDED.

Description of Event or Problem · 0

IT WAS REPORTED BY CUSTOMER THAT PICC LINE GETTING COILED AFTER CT (PHI). NO OTHER INFORMATION WAS PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1153421 BARD PICC 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 Other