MAUDE Adverse Event Report: COVIDIEN HYPO NEEDLE 18GX1 1/2 A BEV RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881250016
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2019
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.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 a bug was found on the needle itself (not embedded) when the cap was taken off.

• Brand Name: HYPO NEEDLE 18GX1 1/2 A BEV RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8982836
• Report Number: 1017768-2019-00681
• Device Sequence Number: 365064
• Product Code: FMI
• UDI-Device Identifier: 20884521138237
• UDI-Public: 20884521138237
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/10/2019

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: 8881250016
• Device Catalogue Number: 8881250016
• Device Lot Number: 906313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1