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	Malfunction
Event or Problem Description
Omi's customer cardinal health emailed their event form to report their customer, (b)(6)hospital had a lancet not retract after using on a fingersitck and as a result the rn performing the procedure was stuck with the used needle.
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 and none has been provided.Om inc followed up three times trying to obtain a medical questionnaire and one was not returned.

• 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
• Manufacturer (Section G): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• Manufacturer Contact: patty haney ; 1755 west oak commons ct.; marietta, GA 30062 ; 7709772226
• MDR Report Key: 17406381
• Report Number: 8021764-2023-00004
• Device Sequence Number: 5900411
• Product Code: FMK
• UDI-Device Identifier: 20885380065955
• UDI-Public: 20885380065955
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K221126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown