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

Model Number	31G X 6MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called stating that hi pen needles are clogged.He is unable to prime them.He does not reuse pen needles.He states that this happened a few times last month with his boxes but, this month he has gone through 1/2 the box and most are defective.

• Brand Name: MEMBER'S MARK 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: 11811214
• Report Number: 9613304-2021-00016
• Device Sequence Number: 16931163
• Product Code: FMI
• UDI-Device Identifier: 10078742257744
• UDI-Public: (01)10078742257744(17)250401(10)A46J6
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: 04/01/2025
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8932
• Device Lot Number: A46J6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1