MAUDE Adverse Event Report: BIOLIFE, LLC STATSEAL POWDER

Model Number LP006

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

Patient Problem Bacterial Infection (1735)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

Biolife's medical advisor documented an evaluation of the incident.

Event Description

Rn called biolife customer care department to report a central line-associated bloodstream infection (clabsi) event after using statseal powder on a (b)(6) week patient.The patient was identified with staph aureus bloodstream infection four (4) days after picc insertion.The type, size and location of the catheter was argyle dual lumen 1.9fr.Rt basilic; the line was secure with steristrips and tegaderm.The patient required increased system support, went from cpap to full ventilation.Infant described as now "stable and improving.The nurse stated that it was challenging to achieve hemostasis, applied multiple layers of staseal powder, and hemostasis was achieved after approximately five (5) minutes, with an amount of powder described as a "large clump".

• Brand Name: STATSEAL POWDER
• Type of Device: STATSEAL POWDER
• Manufacturer (Section D): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• MDR Report Key: 12715455
• MDR Text Key: 281336735
• Report Number: 1066421-2021-00003
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K080210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LP006
• Device Catalogue Number: LP606
• Device Lot Number: 062105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2021
• 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): Life Threatening; Other
• Patient Age: 23.5 WK