MAUDE Adverse Event Report: COVIDIEN MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833558
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that during vaccine administration, the needle separated from syringe and vaccine ran down client's arm.
Additional Manufacturer Narrative
The device history record (dhr) for lot 631984 indicates that here were zero defects found in 572 visual samples and zero defects found in 802 physical samples inspected from the lot.There were no samples submitted with this complaint.The reported condition could not be confirmed without an actual sample to evaluate.The exact root cause could not be determined based on available information.A 6m root cause investigation was conducted and reviewed several potential contributing factors.There was one potential root cause identified that could not be discarded from consideration.The most probable root cause was potentially due to improperly seating the needle to the syringe by the user.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 luer taper, hub leakage and damage.The lot met all defined acceptance criteria and was released.The investigation did not identify a systemic issue with the product or process.The investigation identified a potential root cause that is unrelated to the manufacture of the safety needle.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.It¿s recommended the user consults the instructions for use for guidance when attaching the device.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; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 6993123
• Report Number: 1017768-2017-05160
• Device Sequence Number: 13716009
• Product Code: FMI
• UDI-Device Identifier: 10884521005846
• UDI-Public: 10884521005846
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 10/31/2021
• Device Model Number: 8881833558
• Device Catalogue Number: 8881833558
• Device Lot Number: 631984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 01/18/2018
• Patient Sequence Number: 1