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

Model Number 1180600777

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

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 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9722507
• MDR Text Key: 180400104
• Report Number: 1915484-2020-01130
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180600777
• Device Catalogue Number: 1180600777
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1