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

Model Number	31G X 5MM
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tests on archival sample were performed for compliance with the parameters established in product specifications.No defects or other nonconformities were found.The tests on customer sample were performed for compliance with the parameters established in product specifications.The defects under complaint were not confirmed in the sample from customer.The defect was caused by user, because user do not follow instructions for use according to disassembly pen needle from pen injector.
Event or Problem Description
Customer is having an issue with the needles bending.He also stated he has to press very hard for the needles to penetrate his skin.

• Brand Name: MEMBER'S MARK PEN NEEDLES
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 7880523
• Report Number: 9613304-2018-00030
• Device Sequence Number: 2508328
• Product Code: FMI
• UDI-Device Identifier: 10078742257737
• UDI-Public: (01)10078742257737(17)230101(10)Y46A5
• 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): 08/14/2018

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: 01/01/2023
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8931
• Device Lot Number: Y46A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1