CATHETER PICC POLYURETHANE INSERTION KIT W/INTRODUCER 1.4FR
Received Apr 28, 2026 · Event occurred Apr 17, 2026
Report MW5187368 · MDR key 25017474
Device
Generic name
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer
Footprint Medical Inc.Catalog number
P1PIC1.4-S
Lot number
250708
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE HAVE HAD 2 PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINES WITH THE SAME LOT NUMBER THAT WERE DIFFICULT TO REMOVE FROM NEONATAL INTENSIVE CARE UNIT PATIENTS. ONE ACTUALLY FRACTURED IN THE INFANT REQUIRING THEM TO GO TO (B)(6) TO HAVE IT SURGICALLY REMOVED. FOR THIS INCIDENT HE WAS ABLE TO FULLY REMOVE THE CATHETER FROM THE PATIENT; HOWEVER, IT TOOK 2 HOURS TO SAFELY REMOVE. THE LOT NUMBER (250708) MATCHES THE LOT NUMBER OF THE PATIENT WE HAD TO TRANSFER OUT DUE TO A RETAINED PORTION OF A PICC LINE ON 3/29. BOTH OF THESE PATIENTS HAD A 1.4FR FOOTPRINT CATHETER INSERTED WITH. PLEASE LET US KNOW IF THERE IS ANY ADDITIONAL INFORMATION WE CAN PROVIDE. THANK YOU.