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)
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 reports that the safety device on the butterfly will not engage, and when it does engage, the device comes loose causing the needle to stick.One needle stuck after use.The customer further states that the product does not engage; it also became loose and one needle got stuck.
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the complaint states that the safety device on butterfly will not engage, and when it does engage, the device comes loose causing the needle to stick.One needle stuck after use.The customer further states that the product does not engage it also became loose and one needle got stuck.¿ a review of the device history record (dhr) was conducted identifying no additional information.No sample was received for evaluation.Therefore, no potential corrective actions could be identified.The reported complaint could not be confirmed.A root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6533093
• Report Number: 1282497-2017-05114
• Device Sequence Number: 978365
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 03/31/2017; 08/08/2018
• Initial Report FDA Received Date: 04/30/2017
• Supplement Report FDA Received Date: 07/26/2018; 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other