MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET 31G X 8MM PEN NEEDLES

Model Number	31GX8MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient is a diabetic who is physically handicap and also visually impaired.She recently started using your droplet pen needles and has found after her injection, when she attempts to replace the outer/larger needle cap to cover the actual needle, the outer cap does not stay secure on the needle's plastic ring.When removing the needle from the pen, the outer cap falls off and a person can easily be poked with the needle.This does not only happen to her but other caregivers who are giving her injections.
Event or Problem Description
The patient is a diabetic who is physically handicap and also visually impaired.She recently started using your droplet pen needles and has found after her injection, when she attempts to replace the outer/larger needle cap to cover the actual needle, the outer cap does not stay secure on the needle's plastic ring.When removing the needle from the pen, the outer cap falls off and a person can easily be poked with the needle.This does not only happen to her but other caregivers who are giving her injections.

• Brand Name: DROPLET 31G X 8MM PEN NEEDLES
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 13822735
• Report Number: 9613304-2022-00003
• Device Sequence Number: 16694617
• Product Code: FMI
• UDI-Device Identifier: 05907996093052
• UDI-Public: (01)05907996093052(17)260601(10)B56M8
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 06/01/2026
• Device Model Number: 31GX8MM
• Device Catalogue Number: 8309
• Device Lot Number: B56M8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female