MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833558
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device may not be returned for evaluation; 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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the magellan syringe was broken at the hub.There was no patient injury reported.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10556916
• Report Number: 1017768-2020-00869
• Device Sequence Number: 3578022
• Product Code: FMI
• UDI-Device Identifier: 10884521005846
• UDI-Public: 10884521005846
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 8881833558
• Device Catalogue Number: 8881833558
• Device Lot Number: 907744
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/18/2020
• Patient Sequence Number: 1