MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE SAFETY LANCET; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE

Model Number	MPHPRESS30
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with type 1 diabetes mellitus; lancet used to draw for blood sugars sliced patient's finger (no other descriptions available) and staff said similar occurrences lately - this specific device not saved but team presented safety report to track & trend and they saved the balance of the lancets in the box from which they procured subject lancet.No residual issue nor injury to patient and no treatment noted.

• Brand Name: MEDLINE SAFETY LANCET
• Common Device Name: SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 20236273
• Report Number: 20236273
• Device Sequence Number: 12950454
• Product Code: FMK
• UDI-Device Identifier: 30884389103023
• UDI-Public: (01)30884389103023
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/28/2024
• Report Date (Section F): 05/28/2024

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: Health Professional
• Device Model Number: MPHPRESS30
• Device Catalogue Number: MPHPRESS30
• Device Lot Number: (10)2310284802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• 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 Age: 21 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 05/28/2024