MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 18 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850810
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2019
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the hub cracked where it attaches to the syringe causing the medication/vaccination to leak out.

• Brand Name: SAFETY NEEDLE 18 X 1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8949694
• Report Number: 1017768-2019-00673
• Device Sequence Number: 19437390
• Product Code: FMI
• UDI-Device Identifier: 10884521000582
• UDI-Public: 10884521000582
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: 8881850810
• Device Catalogue Number: 8881850810
• Device Lot Number: 904518
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/30/2019
• Patient Sequence Number: 1