MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833310
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The nursing staff reported that one moderna vaccine dose, lot number 026a21a, leaked on the sides of the syringe where the needle is attached to the syringe itself and the vaccine did not provide the full 0.5 ml dose.There was no patient harm reported.
Additional Manufacturer Narrative
The manufacturing date has been added.(initial reporter name and address) was originally listed as (b)(6), e-mail: mailto:(b)(6), phone number: (b)(6) and should be (b)(6).

• Brand Name: MAGELLAN 3ML SFTY COMBO 23X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11610556
• Report Number: 1017768-2021-00918
• Device Sequence Number: 3667303
• Product Code: FMI
• UDI-Device Identifier: 10884521005815
• UDI-Public: 10884521005815
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/08/2021

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 Expiration Date: 10/31/2025
• Device Model Number: 8881833310
• Device Catalogue Number: 8881833310
• Device Lot Number: 034941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/08/2021
• Patient Sequence Number: 1