MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE 31G X 8MM

Model Number	31G X 8MM
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient called in today stating that his pen needle is bending and breaking each time he injects.Over the last 3-5 months he has had 8-12 pn break off into his skin.He alternates injection sites and no matter where he sticks, the pn breaks.His last 2 pn broke off.Most times he can pull the broken needles out of the injection site but a couple of times he was unable to find it.He doesn't feel discomfort so he is unsure if its in his abdomen or just fallen and lost somewhere.

• Brand Name: DROPLET PEN NEEDLE 31G X 8MM
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 12273087
• Report Number: 9613304-2021-00025
• Device Sequence Number: 4664033
• Product Code: FMI
• UDI-Device Identifier: 05907996099405
• UDI-Public: (01)05907996099405(17)251201(10)A56ZC6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 12/01/2025
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8309
• Device Lot Number: A56ZC6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1