MAUDE Adverse Event Report: COVIDIEN HYPO NEEDLE 27X1 1/2 A BEVEL; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1188827112
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2019
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 to the distributor that the device will not lock into the syringe; the needle blows off the syringe.Additional information received from the customer stated that the issue happened during case-set up.The customer further stated that when they attempt to put the needle on the syringe it does not lock.They tried several needles and syringe combinations and it was always the needle that had the problem.

• Brand Name: HYPO NEEDLE 27X1 1/2 A BEVEL
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9318582
• Report Number: 1017768-2019-00734
• Device Sequence Number: 19423284
• Product Code: FMI
• UDI-Device Identifier: 10884521007444
• UDI-Public: 10884521007444
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 1188827112
• Device Catalogue Number: 1188827112
• Device Lot Number: 908708
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1