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

Model Number	31G X 8MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Missing Value Reason (3192)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient received 4 boxes of droplet 31g x 8mm with lot no.Y56f8.He uses flex pen to inject 4x per day.User called in stating that the pn don't work.He states that no insulin comes out the pn as if they're clogged.He doesn't reuse pn.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 9928215
• Report Number: 9613304-2020-00010
• Device Sequence Number: 2732428
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)230301(10)Y56F8
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 31G X 8MM
• Device Catalogue Number: 8315
• Device Lot Number: Y56F8
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1