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

Model Number	1180300777
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the air is entering into the syringe with the blood sample.
Additional 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
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724
• MDR Report Key: 9158664
• Report Number: 1915484-2019-01091
• Device Sequence Number: 19325749
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 920000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1