MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. "VASCULAR" PACK, 30 CC SYRINGE; SYRINGE, PISTON

Model Number DYNJ49366

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  malfunction  

Event Description

Leur lock of the 30 cc syringe contained in the medline industries.Vascular pack, does not secure the heparin needle.This allows for the heparin needle to separate from the syringe while in use.Fda safety report id# (b)(4).

• Brand Name: "VASCULAR" PACK, 30 CC SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 8907174
• MDR Text Key: 154957091
• Report Number: MW5089137
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DYNJ49366
• Device Catalogue Number: DYNJ49366
• Device Lot Number: 19EBT109
• 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