MAUDE Adverse Event Report: COVIDIEN LP/LLC, DELAND MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850515
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer reported that the safety shield is not engaging, leaving the needle exposed.
Additional Manufacturer Narrative
The device history record (dhr) for lot 718127 indicates that there were zero defects found in 544 visual samples and zero defects found in 694 physical samples inspected from the lot.A review of the entire dhr did not identify and manufacturing or inspection anomalies.There were 21 samples (unopened) submitted with this complaint.The samples were inspected for damage, shield stall/locking and needle free length according to the magellan safety needle quality and inspection standard.All samples passed inspection and met manufacturing specifications.The reported condition could not be confirmed.The exact root cause could not be determined based on available information.A 6m root cause investigation was conducted and determined the most likely root cause to be due to user error, improper activation technique.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for needle free length and shield stalling/lock failure.The product met all defined acceptance requirements and was released.Based on the investigation and root cause analysis, the initiation of a formal corrective and preventative action (capa) is not required.The condition was most likely a result of user error.It¿s recommended the user consult the instructions for use included with the product for guidance.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN LP/LLC, DELAND; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 6994514
• Report Number: 1017768-2017-05161
• Device Sequence Number: 1183722
• Product Code: FMI
• UDI-Device Identifier: 20884521145044
• UDI-Public: 20884521145044
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 8881850515
• Device Catalogue Number: 8881850515
• Device Lot Number: 718127
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1