MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. FOOTPRINT MEDICAL INC. 1.4 FR PEEL-AWAY SHEATH INTRODUCER; INTRODUCER, CATHETER

Model Number	P1PIC1.4-S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Footprint medical inc., 1.4 fr peel away sheath introducer did not completely split.A portion of the sheath was left encircling the catheter and the sheath could not be removed after the catheter was inserted into the extremely premature baby's arm.As a result the catheter had to be removed and replaced.Fda safety report id# (b)(4).

• Brand Name: FOOTPRINT MEDICAL INC. 1.4 FR PEEL-AWAY SHEATH INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; san antonio TX
• MDR Report Key: 10683281
• Report Number: MW5097221
• Device Sequence Number: 3483180
• Product Code: DYB
• UDI-Device Identifier: 00858778006072
• UDI-Public: (01)00858778006072(17)220508(01)
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: P1PIC1.4-S
• Device Lot Number: 200694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 DA
• Patient Weight: 1