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

Model Number	31G X 8MM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
User received 2 boxes pen needle from save on pharmacy with lot no.Z58r2.She injects 40 units of tojeo 1x per day with the corresponding pen.She called in stating that pn 'came apart in her side.' she said it was hard to inject the pn.When she removed pulled back, the pn was sticking out the side of her stomach.She had to pull it out with her fingers.She does not reuse pns.

• 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: 9966351
• Report Number: 9613304-2020-00011
• Device Sequence Number: 19943983
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)240801(10)Z58R2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• 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): 03/11/2020

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: 08/01/2024
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8315
• Device Lot Number: Z58R2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1