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

Model Number	31G X 8MM
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Missing Value Reason (3192)
Type of Reportable Event	Malfunction
Event or Problem Description
User bought (4) boxes of mm 31g x 8mm pen needles with lot no.Y46zc2.He injects 5-10 units of humalog on a sliding scale 1x per day with the corresponding pen.He called because his pn is breaking inside the pen somehow.This has happened several times.Wife was able to push one pn tip out of the pen by pressing really hard but, the others could not be removed which makes the actual pen useless.

• Brand Name: MEMBER'S MARK
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow 95-03 5; PL 95-035
• MDR Report Key: 9503027
• Report Number: 9613304-2019-00084
• Device Sequence Number: 1215301
• Product Code: FMI
• UDI-Device Identifier: 20078742257758
• UDI-Public: (01)20078742257758(17)230801(10)Y46ZC2
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/20/2019

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: No Information
• Device Expiration Date: 08/01/2023
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8933
• Device Lot Number: Y46ZC2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1