MAUDE Adverse Event Report: OWEN MUMFORD LTD AUTOJECT 2 FOR GLASS SYRINGE; INJECTOR

Model Number	AJ 1060
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided for any type of follow up.There is no information given for us to conduct any type of review and the reported complaint on the medwatch is not conclusive that the reported malfunction is due to the device or the patient not using properly.
Event or Problem Description
A patient complained to their pharmacy who submitted a medwatch: patient attempted to use autoject device and it would not inject.Date of occurrence is unknown.The patient used a prefilled syringe to administer their dose.

• Brand Name: AUTOJECT 2 FOR GLASS SYRINGE
• Common Device Name: INJECTOR
• Manufacturer (Section D): OWEN MUMFORD LTD; brook hill; woodstock, OX20 1TU; UK OX20 1TU
• MDR Report Key: 9571919
• Report Number: 8021764-2020-00001
• Device Sequence Number: 2133438
• Product Code: KZH
• UDI-Device Identifier: 15016189106015
• UDI-Public: 15016189106015
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K122837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2020
• Report Date (Section F): 01/09/2020

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: Lay User/Patient
• Device Model Number: AJ 1060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2019
• Date Report to Manufacturer: 01/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/09/2020