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

Model Number 26547

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9520908
• MDR Text Key: 173084667
• Report Number: 1017768-2019-00767
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479201054
• UDI-Public: 10612479201054
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 26547
• Device Catalogue Number: 26547
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1