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

Model Number DYND20325

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2021

Event Type  malfunction  

Event Description

Sterile piston syringe has hair-like appearing item within the sterile packaging (never opened).Fda safety report id # (b)(4).

• Brand Name: PISTON SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; northfield IL 60093
• MDR Report Key: 12421430
• MDR Text Key: 270098953
• Report Number: MW5103704
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND20325
• Device Catalogue Number: DYND20325
• Device Lot Number: 96921010001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR