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); Skin Tears (2516)

Event Date 07/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A 1 fr picc was placed on (b)(6) 2021 @ 1730 for nutritional needs on a 23-week gestational child.The inserting rn dressed the site with "half of an extra-small (dt) statseal disc".The site was dressed per their normal procedure, the catheter was secured with steri-strips and transparent dressing, and this dressing remain clean, dry and intact for the cource of picc treatment with no obvious signs or symptoms of injury.On 07-18-2021 the child began to feed orally and parenteral nutrition was discontinued.At this time the picc and disc dressing were removed and small wound was noted at the point of disc/skin contact.Wound care was consulted and they treated the wound with antimicrobial ointment and prophylactic antiobiotic intravenous infusion.The inserting rn informed biolife clinician on (b)(6) 2021 at 1500.Patient primary diagnosis : pre-mature, respiratory distress, weighing 560-grams four (4) days old at the time of application.Patient outcome: the wound initially described as 0.6-0.8cm when the half statseal disc was removed.Nurse reports it appears to be improving as of (b)(6) 2021 with no signs or symptoms of infected reported.Bacitracin was the topical treatment for the wound and prophylactic vancomycin & gentamicin infusion.The child is consuming nutrition and is described as being in no acute distress.

• 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: 12276951
• MDR Text Key: 265174983
• Report Number: 1066421-2021-00001
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130324
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: DT613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 4 DA
• Patient Weight: 56