MAUDE Adverse Event Report: HTL-STREFA S.A. MEMBER'S MARK PEN NEEDLE

Model Number	32G X 4MM
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient pushes the plunger and the dialed units is not delivered.Says only half the units comes out ~usually around 15-18 units.When this happen, she simply replaces the pen needle 'tip' as she calls it uses 90-degree injection technique as recommended by her doctor.Injects 1x per day.Uses lantus solostar - injects 37 units, she does not reuse her needles, she has 12 left in the box.

• Brand Name: MEMBER'S MARK PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8526754
• Report Number: 9613304-2019-00044
• Device Sequence Number: 1884325
• Product Code: FMI
• UDI-Device Identifier: 10078742257720
• UDI-Public: (01)10078742257720(17)230301(10)Y58F7
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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 Expiration Date: 03/01/2023
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8930
• Device Lot Number: Y58F7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1