MAUDE Adverse Event Report: COVIDIEN MONOJECT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8881225307
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer states that the product does not engage it also became loose and one needle got stuck.

• Brand Name: MONOJECT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 92173 ; MX 92173
• MDR Report Key: 6533107
• Report Number: 9612030-2017-05064
• Device Sequence Number: 16335612
• Product Code: FOZ
• UDI-Device Identifier: 20884521013398
• UDI-Public: 20884521013398
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 8881225307
• Device Catalogue Number: 8881225307
• Device Lot Number: 162740286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other