MAUDE Adverse Event Report: COVIDIEN "SAFETY NEEDLE 23GX1 BULK, NS"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	7777850310
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a foreign material imbedded in the plastic on the one piece of component.Additional information received from the customer states the contamination is on the shield and the hub.The customer also mentioned that they cannot confirm that the particle wouldn't be on the fluid path.

• Brand Name: "SAFETY NEEDLE 23GX1 BULK, NS"
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8743971
• Report Number: 1017768-2019-00652
• Device Sequence Number: 11336900
• Product Code: FMI
• UDI-Device Identifier: 10884521155534
• UDI-Public: 10884521155534
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 7777850310
• Device Catalogue Number: 7777850310
• Device Lot Number: 708401 OR 708141
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1