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

Model Number	31G X 5MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient has had difficulty injecting with all 3 boxes he has received.He pushes hard to inject and they do not puncture the skin easily.
Event or Problem Description
Patient has had difficulty injecting with all 3 boxes he has received.He pushes hard to inject and they do not puncture the skin easily.

• Brand Name: DROPLET 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: 7933064
• Report Number: 9613304-2018-00050
• Device Sequence Number: 1665443
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)230201(10)Y56C9
• 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,Followup
• Report Date (Section B): 09/18/2018

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: 02/01/2023
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8310
• Device Lot Number: Y56C9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1