MAUDE Adverse Event Report: OWEN MUMFORD LIMITED CARDINAL HEALTH SAFETY LANCETS LOW FLOW

Model Number	AT 6204
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The rn contact details were not given to owen mumford.We have had to rely on cardinal health to obtain more information needed, and it has not been provided.We followed up three times to try to obtain a medical questionnaire with more details, but it was never returned.Cardinal health also communicated that they had sent one of their own questionnaires that they also did not recieve back.We have no additional information.
Event or Problem Description
Customer emailed with event form to report that their customer barnes jewish hospital had a lancet not retract after using on a fingerstick and as a result the rn performing the procedure was stuck with the used needle.

• Brand Name: CARDINAL HEALTH SAFETY LANCETS LOW FLOW
• Common Device Name: LANCET
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 17406380
• Report Number: 1058602-2023-00004
• Device Sequence Number: 5900410
• Product Code: FMK
• UDI-Device Identifier: 20885380065955
• UDI-Public: 20885380065955
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023
• Report Date (Section F): 07/27/2023

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 Model Number: AT 6204
• Device Lot Number: 05919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/27/2023