MAUDE Adverse Event Report: MAGNOLIA MEDICAL TECHNOLOGIES, INC. STERIPATH; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 2700-21-EN

Device Problems Retraction Problem (1536); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Event Description

The needle in the steripath 21 g collection device is retracted into the safety position before opening the package, rendering the product unusable.All of them found have the lot number: 9446991.Out of the 30 in the lab's stock, 17 are bad.We checked all other steripath 21 g collection devices in the lab and set any bad ones aside.

• Brand Name: STERIPATH
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): MAGNOLIA MEDICAL TECHNOLOGIES, INC.; 200 west mercer street ste 500; seattle WA 98119
• MDR Report Key: 11169546
• MDR Text Key: 226786617
• Report Number: 11169546
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2020,12/07/2020

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
• Device Operator: No Information
• Device Catalogue Number: 2700-21-EN
• Device Lot Number: 9446991
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1