MAUDE Adverse Event Report: BIOLIFE, LLC STATSEAL; STATSEAL POWDER

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biolife clinician reviewed statseal powder application instruction for use with the nurse, which includes tips for success.Nurse stated that she was going to review with staff regarding no excess pressure during hold times, no pressure dressing or posey on top of site, and using appropriate amount of powder.The nurse was also planning to discuss with her medical director.There are not any contraindications with using statseal powder.Biolife have documented qualified evaluation of the adverse event from biolife's chief medical advisor.
Event or Problem Description
(b)(6); (b)(6) weeks- old, maybe a little older like (b)(6)- weeks old-micro-preemie.Born on (b)(6) 2020.On (b)(6) 2020, a baby had a picc line place in the left antecubital fossa(ac) with statseal powder and no pcd.A little larger amount of powder than normal according to the nurse, it was a, "pretty big pile for that size baby." on (b)(6) 2020, the picc line was required to be pulled back, and therefore, the dressing was removed.They discovered a black necrotic area around the insertion site under where the statseal powder had been.The wound measure 1.25cm x 0.75cm.There was a lot of oozing.Unable to get other iv access so this picc line remained in place in the left ac.Wound team called and mepitel ag dressing applied on picc line site.Baby had very fragile skin.When biolife's clinician asked the nurse about co-morbidities; nurse said no but "really sick" with failure to urinate, became very edematous right away, poor perfusion.Baby died on (b)(6) 2020, unrelated to this wound.Nurse stated was not septic.Their standard is to place a posey (foam strap with velcro) on extremity at the hub of a picc line, and tegaderm to prevent the tubing from pulling the tegaderm.This baby had the posey on top of the dressing over the picc site, using as a pressure dressing.

• Brand Name: STATSEAL
• Common Device Name: STATSEAL POWDER
• Manufacturer (Section D): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• MDR Report Key: 10935685
• Report Number: 1066421-2020-00004
• Device Sequence Number: 3711376
• Product Code: FRO
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/02/2020
• 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: 26 WK
• Patient Weight: 855