MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1180600777
Medical Device Problem Codes	Fluid/Blood Leak (1250); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that while in the ed, the nurse pull back on the plunger of the syringe to withdraw blood, then the blood sprayed through the back side of the syringe and splashed to the nurse.Additional information was received on 17-feb-2020 stating that the plunger seems to be too small for the cannula and the seal was poor.The nurse had a direct skin exposure to the patient's blood.The nurse was not harmed.No medical intervention required.

• Brand Name: 6ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9722507
• Report Number: 1915484-2020-01130
• Device Sequence Number: 329692
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: 1180600777
• Device Catalogue Number: 1180600777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/18/2020
• Patient Sequence Number: 1