MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 20 X 1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850015
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
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 while tapping bubbles out of a medication that was drawn up, it was noticed that the bottom of the needle was cracked.The medication sprayed onto the ma's arm.There was no harm to the ma or the patient.

• Brand Name: SAFETY NEEDLE 20 X 1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11866650
• Report Number: 1017768-2021-00943
• Device Sequence Number: 19764256
• Product Code: FMI
• UDI-Device Identifier: 10884521000490
• UDI-Public: 10884521000490
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/21/2021

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: 8881850015
• Device Catalogue Number: 8881850015
• Device Lot Number: 0174497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/21/2021
• Patient Sequence Number: 1