MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 23 X 1; SYRINGE, PISTON

Model Number	26547
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the nurse found medication dripping down the patient's arm and noticed the needle was leaking.

• Brand Name: PREVENT 3ML COMBO 23 X 1
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9520908
• Report Number: 1017768-2019-00767
• Device Sequence Number: 13529581
• Product Code: FMF
• UDI-Device Identifier: 10612479201054
• UDI-Public: 10612479201054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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: 26547
• Device Catalogue Number: 26547
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/26/2019
• Patient Sequence Number: 1