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

Model Number	32G X 4MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
The user called in to let us know her pen needle won't dispense all of the units she is dialing at one time.She takes 36 units once a day and has to use 4 needles occasionally to get all of her insulin.She uses a xultophy pen and she primes each time.She says that after she inserts the needle and starts to depress, it make a loud clicking noise and then the insulin stops.She has to change the needle at that point.

• Brand Name: MEMBER'S MARK
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 9966377
• Report Number: 9613304-2020-00013
• Device Sequence Number: 4442243
• Product Code: FMI
• UDI-Device Identifier: 10078742257720
• UDI-Public: (01)10078742257720(17)240701(10)Z58W3
• Combination Product (Y/N): N
• 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): 03/12/2020

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: 07/01/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8930
• Device Lot Number: Z58W3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1