MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number 1180300777

Device Problem Improper Flow or Infusion (2954)

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

Event Date 10/02/2019

Event Type  malfunction  

Event Description

The customer reported that the air is entering into the syringe with the blood sample.

Manufacturer Narrative

Update d2: brand name description.Update: d3 manufacturer address.Update: d4 model number from 1180600777 to 1180300777 & udi number.

• Brand Name: 3ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724
• MDR Report Key: 9158664
• MDR Text Key: 165233019
• Report Number: 1915484-2019-01091
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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 Model Number: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 920000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 02/03/2020
• Patient Sequence Number: 1