MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE; PEN NEEDLES

Model Number	31G X 8MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reports having trouble with this pen needle.States it isn't working right, not dosing insulin correctly.

• Brand Name: DROPLET PEN NEEDLE
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8356928
• Report Number: 9613304-2019-00034
• Device Sequence Number: 13987879
• Product Code: FMI
• UDI-Device Identifier: 05907996093052
• UDI-Public: (01)05907996093052(17)230501(10)Y56M1
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: 05/01/2023
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8309
• Device Lot Number: Y56M1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1