MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3MLSFTY COMB 22X1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833215
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.  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 customer reported that the medication was spilling out at the side of the syringe, near the top of the syringe on the end, where the plunger inserts.The customer believes, it must have been near that end because he was able to draw up the medication fine, with no apparent problems or cracks.The medication shot out from the side of the syringe.There were two streams from the same general locations, which implies a crack of some sort.The patient was administered ativan 2 mg with haldol 10 mg (a total of 3 ml).The patient did not appear to get any of the medication that was administered, and the staff stopped injecting about halfway through the syringe being emptied.The patient appeared to suffer no consequences other than an extra poke.

• Brand Name: MAGELLAN 3MLSFTY COMB 22X1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10294991
• Report Number: 1017768-2020-00833
• Device Sequence Number: 3064689
• Product Code: FMI
• UDI-Device Identifier: 10884521005792
• UDI-Public: 10884521005792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/20/2020

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: 8881833215
• Device Catalogue Number: 8881833215
• Device Lot Number: 924031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1