MAUDE Adverse Event Report: COVIDIEN MAGELLAN TB 1 ML 27X1/2; SYRINGE, PISTON

Model Number	8881882712
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will 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 they attempted to give a patient lovenox but it would not inject.When they removed the needle from the patient and looked at it closer, the health care provider was able to pull the plunger back but when they pushed it forward it would not inject.They tried to look for any occlusion and could not see any.The plunger would pull back to aspirate, but would not move forward to inject.

• Brand Name: MAGELLAN TB 1 ML 27X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9588855
• Report Number: 1915484-2020-01121
• Device Sequence Number: 17062518
• Product Code: FMF
• UDI-Device Identifier: 20884521005911
• UDI-Public: 20884521005911
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 8881882712
• Device Catalogue Number: 8881882712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1