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

Model Number	AJ 1060
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 for us to conduct any type of review and the reported complaint on the medwatch is not conclusive that the device "broke" due to misuse or how the device is "broke".
Event or Problem Description
Patient reported to pharmacist that his autoject for copaxone "broke".Pharmacist provided patient with phone number to shared solutions to request new one.Rx meds: copaxone inj 40mg/ml.

• Brand Name: AUTOJECT 2 FOR GLASS SYRINGE
• Common Device Name: AUTOINJECTOR
• Manufacturer (Section D): OWEN MUMFORD LTD; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 9679167
• Report Number: 8021764-2020-00002
• Device Sequence Number: 16296168
• Product Code: KZH
• UDI-Device Identifier: 15016189106015
• UDI-Public: (01)15016189106015(10)XXX(11)YYMMDD
• Combination Product (Y/N): Y
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020
• Report Date (Section F): 02/06/2020

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: 01/06/2020
• Event Location: Home
• Date Report to Manufacturer: 01/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/06/2020
• 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: 02/06/2020