MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833510
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the needle was improperly attached to the luer of the syringe.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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, all lots are examined for correct assembly and packaging.The lot met all defined acceptance requirements and was released.One (1) opened sample with lot number 820834 has the needle subassembly inside of the packaging with the barrel separated from the packaging and needle subassembly.The picture provided with the complaint record of the opened sample in the kit also shows that the luer taper tip on the barrel was not fully engaged with the luer lock hub on the needle subassembly.Therefore, the reported condition is confirmed.A specific root cause could not be determined based on the available information.The investigation did not identify a systemic issue with the product or process.A corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9450736
• Report Number: 1017768-2019-00749
• Device Sequence Number: 14225804
• Product Code: FMI
• UDI-Device Identifier: 10884521005839
• UDI-Public: 10884521005839
• 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): 03/09/2020

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: No Information
• Device Model Number: 8881833510
• Device Catalogue Number: 8881833510
• Device Lot Number: 820834
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1