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

Model Number	31G X 5MM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This defect was most probably caused by the higher than usual force holding the cannula inside the rubber plug of the vial, exceeding the strength of bond of cannula and needle hub.
Event or Problem Description
Patient is having issues removing the pen needle from her insulin pen.Customer has not been injured.

• 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: 7884783
• Report Number: 9613304-2018-00031
• Device Sequence Number: 2049622
• Product Code: FMI
• UDI-Device Identifier: 10078742257737
• UDI-Public: (01)10078742257737(17)230201(10)Y46E9
• 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): 08/20/2018

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 5MM
• Device Catalogue Number: 8931
• Device Lot Number: Y46E9
• 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: 08/20/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1