MAUDE Adverse Event Report: COVIDIEN MONOJECT 20 ML LUERLOCK TIP SYRINGE; SYRINGE PISTON

Catalog Number 1182000777

Device Problems Sticking (1597); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2015

Event Type  malfunction  

Event Description

Doctor attempting to perform routine refill of pt's intrathecal pain pump.After accessing pt's pump, tried to aspirate syringe and plunger portion of syringe popped out and pt's intrathecal medication poured out of syringe.These syringes tend to stick.The doctors prefer a different brand syringes - greater ability to give med slower or to pull back and aspirate.In this case, the docs decided to switch to another brand syringe.

• Brand Name: MONOJECT 20 ML LUERLOCK TIP SYRINGE
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5180033
• MDR Text Key: 29323279
• Report Number: 5180033
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 1182000777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 69 YR