FDA Adverse Event Injury Summary report: N

NA

MDR report key: 23132204 · Received September 24, 2025

Report

Report Number
23132204
Event Type
Injury
Date Received
September 24, 2025
Date of Event
August 25, 2025
Report Date
August 29, 2025
Manufacturer
FOOTPRINT MEDICAL, INC.
Product Code
LJS
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE PLACED ON [DATE REDACTED] DUE TO DIFFICULT VASCULAR ACCESS AND LONG-TERM ANTIBIOTIC TREATMENT. INSERTION SITE: LEFT SAPHENOUS. CATHETER BRAND: FOOTPRINT - LOT # 241352, EXPIRATION 2026-12-19. CATHETER SIZE: SINGLE LUMEN - 1.4 FR/26GAUGE. CATHETER CUT LENGTH: 30 CM. CATHETER INSERTION DEPTH: 27.5 CM. ON [DATE REDACTED] - 7 DAYS LATER @ 1500, CALLED TO BEDSIDE TO CHANGE PICC DRESSING. DRESSING HAD BEEN REINFORCED BUT WAS INTACT. RN AT BEDSIDE TO ASSIST THIS RN. REMOVED DRESSING WITHOUT INCIDENT. 2.5 CM OF PICC OUT (NO CHANGE FROM PREVIOUS). SITE CLEANED WITH CHLORHEXIDINE. SITE FREE FROM REDNESS, SWELLING, OR DRAINAGE. SMALL AMOUNT OR BLEEDING NOTED AFTER CHLORHEXIDINE DRESSING APPLIED PER STERILE TECHNIQUE. DRESSING NOTED TO BE WET FROM PRESUMED LEAKING AT THE SITE. DRESSING REMOVED AND SITE CLEANED AGAIN PER STERILE TECHNIQUE WITH CHLORHEXIDINE. DRIPPING NOTED FROM PICC CATHETER AT ABOUT THE FIRST HASH MARK LINE. PROVIDER AT BEDSIDE. UPDATED ABOUT PLAN TO REMOVED PICC LINE AND PLACE PIV [PERIPHERAL INTRAVENOUS LINE] FOR THE REMAINING ANTIBIOTIC TREATMENT. PICC LINE WITHDREW WITHOUT RESISTANCE UNTIL APPROXIMATELY 8-9 CM. PICC LINE WOULD NOT WITHDRAWAL ANY FURTHER WITH GENTLE TRACTION. TEGADERM APPLIED AND HEAT PACKS APPLIED TO LEG. UNABLE TO WITHDRAWAL PICC LINE WITH GENTLE TRACTION ANY FURTHER DESPITE POSITIONING ATTEMPTS AND HEAT PACKS. TEGADERM AND HEAT PACK REAPPLIED. PICC LINE CLAMPED WITH 2X2 AND HEMOSTAT BELOW HOLE DUE TO BLOOD DRIPPING OUT. LEAKING STOPPED. KUB [KIDNEY, URETER, AND BLADDER XRAY] SHOWS PICC LINE AT L4/5 AND NO VISIBLE KNOT OR LOOPS. PICC TEAM MEMBERS ARRIVED AT BEDSIDE. ATTEMPT TO WITHDRAWAL PICC LINE WITH POSITIONING AND MASSAGE. PICC LINE UNABLE TO BE WITHDRAWN GENTLE TRACTION. PICC LINE COVERED IN TEGADERM. PICC LINE HAD BROKEN. THIS RN CAME IMMEDIATELY TO BEDSIDE. DRESSING REMOVED. PICC LINE SEPARATED AT FIRST HASH MARK. APPROXIMATELY 9 CM OF PICC STILL REMAINS OUTSIDE OF THE INSERTION SITE. TEGADERM REAPPLIED. PROVIDER UPDATED FOR PICC LINE NEEDING REMOVAL. NEXT DAY, [DATE REDACTED] PEDIATRIC SURGEON CAME TO BEDSIDE TO ATTEMPT TO TAKE OUT PICC HIMSELF. THERE WAS RESISTANCE WITH REMOVAL AND PICC LINE WOULD COME OUT AND GO BACK INTO PATIENT AT INSERTION SITE. TUBING REMOVED APPEARED TO BE STRETCHED OUT AND IT APPEARED TO MEASURE >30 CM BUT APPROX. 33.5 CM. SITE WAS COVERED WITH A 2X2 GAUZE AND TEGADERM. LATER IMAGING THAT MORNING SHOWED THAT THERE WAS RETAINED PICC LINE IN PATIENT'S SAPHENOUS VEIN. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF LEFT OVER PICC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1613971 NA CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS FOOTPRINT MEDICAL, INC. P1PIC1.4-C 241352

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Hospitalization| R| L