MAUDE Adverse Event Report: OWEN MUMFORD LIMITED AUTOJECT 2 FOR GLASS SYRINGE; AUTOINJECTOR

Model Number	AJ 1060
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Anxiety (2328)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch mw5092077 received and the only information is that the "pt's wife reported that the pt's autoject2 has not been working properly.She is going to contact the mfr's hub to obtain a new one." there is no other information, no contact information, no information regarding how the device is not working properly or any information as to who the initial reporter was.
Event or Problem Description
Patient's wife reported that his autoject has not been working properly.No other details were given other than she was contact the manufacturer's hub to obtain a new one.

• Brand Name: AUTOJECT 2 FOR GLASS SYRINGE
• Common Device Name: AUTOINJECTOR
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 9712127
• Report Number: 8021764-2020-00003
• Device Sequence Number: 16762947
• Product Code: KZH
• UDI-Device Identifier: 15016189106015
• UDI-Public: (01)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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2020
• Report Date (Section F): 02/14/2020

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
• Device Catalogue Number: AJ1060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2020
• Event Location: Other
• Date Report to Manufacturer: 01/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/14/2020