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

Model Number	31G X 6MM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
User injects insulin and metformin 4-5x daily for about 23 years.She complaints that this has been happening for a while that 'the needles 'bend sometimes, about 2-4 [needles per box]'.When they bend, 'it is the bottom part of the pen needle hub' which is bent before placing needle onto the pen.Also one needle was broken off in the pen and it was push down inside the medicine vial when user had put a new needle.

• Brand Name: MEMBER'S MARK
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9127361
• Report Number: 9613304-2019-00071
• Device Sequence Number: 3069855
• Product Code: FMI
• UDI-Device Identifier: 20078742257741
• UDI-Public: (01)20078742257741(17)231001(10)Y56ZD8
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/26/2019

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: No Information
• Device Expiration Date: 10/01/2019
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8932
• Device Lot Number: Y56ZD8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1