MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SYRINGE, PISTON

Catalog Number SYR100185

Device Problems Degraded (1153); Device Difficult to Setup or Prepare (1487)

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

Event Date 01/21/2023

Event Type  malfunction  

Event Description

The 18-gauge needles supplied are coring vials.Medline hypodermic needle 18 gauge - 1 inch.Ref: syr100185.Black and white box of 100.Multiple technicians experienced coring vials while compounding.

• Brand Name: MEDLINE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 16528803
• MDR Text Key: 311133749
• Report Number: 16528803
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SYR100185
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1