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

Model Number	31G X 8MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
The needles are difficult to penetrate the skin and a pop is heard.Patient also commented that the needle does not feel smooth when inserting/pulling out the needle.

• Brand Name: MEMBER'S MARK PEN NEEDLES
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8077122
• Report Number: 9613304-2018-00067
• Device Sequence Number: 1692172
• Product Code: FMI
• UDI-Device Identifier: 10078742257751
• UDI-Public: (01)10078742257751(17)230201(10)Y58C5
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 02/01/2023
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8933
• Device Lot Number: Y58C5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1