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

Model Number	31G X 5MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
Pen needles hurt and the needles are bending.Sometimes there is a tiny bump after patient removes the needle.She rubs it and the bump disappears in a few hours.
Event or Problem Description
Pen needles hurt and the needles are bending.Sometimes there is a tiny bump after patient removes the needle.She rubs it and the bump disappears in a few hours.

• 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: 8068809
• Report Number: 9613304-2018-00065
• Device Sequence Number: 11158776
• 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,Followup
• Report Date (Section B): 10/18/2018

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: 11/19/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1