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

Model Number	8881850210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/15/17.A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There was one (opened, used) sample submitted with this complaint.The magellan 22x1in needle was returned with a bd 3ml syringe.The needle was damaged from what appeared to be forcible attachment of the device and part of the hub to the needle was completely broken off and remained on the luer of the syringe.The reported condition is confirmed.A 6m analysis was conducted and the most likely root cause is due to over-torqueing the needle onto the syringe during the assembly process 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 hub leaks and damage.The lot met all defined acceptance criteria and was released.Product analysis # (b)(4): product analysis was created by the (b)(4) lab as part of the receipt process, so that decontamination could be documented in (b)(4).This product analysis activity is being marked as ¿complete¿ and the investigating site will create another product analysis activity upon receipt.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
The customer reported the needless hub connection broke in the receiving end of the syringe.

• 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: 6643988
• Report Number: 1017768-2017-05084
• Device Sequence Number: 1122903
• Product Code: FMI
• UDI-Device Identifier: 20884521000534
• UDI-Public: 20884521000534
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 05/22/2017

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: 04/30/2021
• Device Model Number: 8881850210
• Device Catalogue Number: 8881850210
• Device Lot Number: 615249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/15/2017
• Patient Sequence Number: 1