MAUDE Adverse Event Report: COVIDIEN LP/LLC, NORFOLK MONOJECT; SYRINGE, PISTON

Model Number 1183500777

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/22/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a syringe.The customer states technician was drawing up a drug and the drug solution leaked above the plunger into the barrel.

• Brand Name: MONOJECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN LP/LLC, NORFOLK; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer (Section G): COVIDIEN LP/LLC, NORFOLK; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6349936
• MDR Text Key: 68089183
• Report Number: 1915484-2017-05003
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1