MAUDE Adverse Event Report: COVIDIEN 27G X 1 1/4 A (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200508
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the 27g needle leaks.No patient injury was reported.
Additional Manufacturer Narrative
Updated section h6 health effect - impact code from 2199 to 2645 based on information received from the initial reporter.

• Brand Name: 27G X 1 1/4 A (ALUM HUB) RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11118712
• Report Number: 1017768-2021-00892
• Device Sequence Number: 4050528
• Product Code: FMI
• UDI-Device Identifier: 30884521008704
• UDI-Public: 30884521008704
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: 8881200508
• Device Catalogue Number: 8881200508
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/14/2021
• Patient Sequence Number: 1