MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNISTIK 3 COMFORT; LANCET

Model Number	AT 1042
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Anxiety (2328); Discomfort (2330); Patient Problem/Medical Problem (2688)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This lot number was not distributed in the us, however, the same model, at 1042 unistik 3 comfort is distributed in the us.
Event or Problem Description
Owen mumford limited was notified of event on 08 sep 2018 (b)(6).A nurse took a blood sample of a baby in neonatology service with the unistik 3 comfort device.When she was removing her gloves she was injured with the device.She has a mark on the thumb with extensive bleeding, as the needle did not retract entirely into the body of the device.She has not received any follow-up and treatment in terms of serology post nsi, as the patient was negative.
Additional Manufacturer Narrative
Although this lot number of the unistik 3 device had not been distributed in the us, the same model has been in distribution and therefore the event was reported.An investigation was opened on 25 sep 2018 to cover several complaints over a 2 month period stating that unistik 3 comfort device needles were not retracting after use.Full report attached (inv-18-00064 rev 01).- attachment: [inv-18-00064 rev.01.Pdf].

• Brand Name: UNISTIK 3 COMFORT
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 7945160
• Report Number: 8021764-2018-00004
• Device Sequence Number: 1355783
• Product Code: FMK
• UDI-Device Identifier: 00384701042034
• UDI-Public: 00384701042034
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/19/2019
• Report Date (Section F): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: AT 1042
• Device Lot Number: 028163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 02/19/2019
• 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: 10/08/2018