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

Model Number	32G X 4MM
Medical Device Problem Codes	Dull, Blunt (2407); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Shelf box of product had additional label from pharmacy: "use with four times a day flexpen insulin injections" which can suggest multiple injection.There is no proper code for leakage.
Event or Problem Description
Pharmacist was contacted by patient.Patient said the pen needles were difficult to penetrate the skin and also experienced leaking at injection site.

• 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: 8330283
• Report Number: 9613304-2019-00028
• Device Sequence Number: 16410090
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)230501(10)Y58P5
• 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): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: Y58P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1