MAUDE Adverse Event Report: BIOLIFE, LLC STATSEAL DISC

Model Number DT013

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Skin Erosion (2075); Localized Skin Lesion (4542)

Event Date 03/12/2022

Event Type  Injury  

Event Description

On (b)(6), 1.9 fr dl 22 a picc line ordered to be retracted by 0.5 cm.Statseal noted to be saturated under dressing.Once dressing removed statseal had broken into pieces.Once statseal parts clean from insertion site and pressure injurywas visualized.It was approximately 0.5 cm deep and was the diameter of the statseal disc.Medical team notified and picc line was d/c'd.Picc line was evaluated for leaking or breakdown and non noted.Stage 4 pi determined to right axilla.Mepilex was applied to site.Right axilla picc was placed on 3/7, 1.9 fr dl catheter with a hubguard and xs statseal disc.Injury occurred day number 5 after picc placed.Cga of 33 3/7 wks.And dol 2 on (b)(6) (placement date) and cga of 34 3/7 wks.And dol 7 on (b)(6) (event date) and no complications at time of procedure.New picc (1.9 fr sl) was placed (b)(6) 2022 with statseal powder and hubguard placed.Wocn contact on (b)(6) 2022.Braden qd score is 13 at time of assessment.O2 is room air with sats if 92.Stage 4 pi 2x0.8x0.3 sizewith no undermining and no tunnel/induration.Wound bed: 100% moist exposed internal structures including blood vessels, tendons, & muscles.Mild erythema with inflammation and small amount serosanguinous fluid.No s/s of infection.Periwound skin is intact and fully blanchable.On (b)(6) 2022 wound bed is 70% moist exposed inernal structure, 30% granular tissue and with mild erythema with inflammation.Edges are well defined and small amount serosanguinous drainage.No s/s of infection and periwound skin remains intact and fully blanchable.Infact demise on (b)(6) 2022 with nec totalis and not related to event with statseal.

• Brand Name: STATSEAL DISC
• Type of Device: STATSEAL DISC
• Manufacturer (Section D): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• Manufacturer (Section G): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• Manufacturer Contact: claudia masselink ; 8163 25th court east; sarasota, FL 34243 ; 9413601300
• MDR Report Key: 15306892
• MDR Text Key: 298770248
• Report Number: 1066421-2022-00004
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 130324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DT013
• Device Catalogue Number: DT013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 7 DA
• Patient Sex: Male