MAUDE Adverse Event Report: HTL-STREFA S.A. MEMBER'S MARK; PEN NEEDLE

Model Number	31G X 5MM
Medical Device Problem Code	Material Fragmentation (1261)
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 because, her pen needle keep breaking off into her belly.She has been injecting for 4 years and this has never happened.She was switched from other mark to droplet last month.She went through about half of the 1st box and had 20 pn break off into her belly so, she threw the box away thinking the box was defective.She's been using the 2nd box a couple days and has encountered the same issues.She does not reuse pn.We went over her technique and it seems like she is injecting properly; however, she did have hernia surgery around the area she injects so, there could be scar tissue.The broken pen needles removed by patient via tweezers.

• Brand Name: MEMBER'S MARK
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 11341607
• Report Number: 9613304-2021-00004
• Device Sequence Number: 5036214
• Product Code: FMI
• UDI-Device Identifier: 10078742257751
• UDI-Public: (01)10078742257751(17)250201(10)A46C3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• 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): 01/21/2021

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: 02/01/2025
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1