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

Model Number	8881850815
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
Customer at the pharmacy reports: customer uses needle to inject paclitaxel into a chemo mixture.When plunger rod of bd syringe is depressed, medication leaks out of medtronic needle hub.The customer explains that compounders put more pressure on the piston of the syringe, causing more pressure behind the needle.This causes needle threads to be stripped, and needle/syringe become separated, and cause a leak.
Additional Manufacturer Narrative
The device history record (dhr) for lot 707422 indicates there were zero defects found in 544 visual samples and zero defects found in 694 physical samples inspected from the lot.There were no non-conformance reports (ncr)s issued to this lot.There were no samples returned 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 multiple potential contributing factor.There were two potential root causes identified that could not be discarded from consideration.The first was potentially related to user error and the second was potentially related to dimensional variation of the syringe that was sourced by the customer.However, these factors could not be assessed any further without an actual sample to evaluate.The complaint file contains insufficient evidence to determine a most probable root cause.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 manufacturing process.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: 6748415
• Report Number: 1017768-2017-05111
• Device Sequence Number: 16528652
• Product Code: FMI
• UDI-Device Identifier: 20884521000602
• UDI-Public: 20884521000602
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 8881850815
• Device Catalogue Number: 8881850815
• Device Lot Number: 707422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1