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

Model Number	31G X 8 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
User has been injecting insulin for over 20 years but is new to the droplet brand.User claims that every needle she used would bend during her injection, so that each patient end of the needle was bent over when she removed the needle.She claims that 4 needles broke off of the pen needle base and got stuck in her stomach after injection.She did not seek medical attention.She was able to remove them by cutting a small slit into the injection site to retrieve the needle.Patient has used different brand needles before and has not had any problems.

• Brand Name: DROPLET PEN NEEDLES 31G X 8MM
• Common Device Name: PEN NEEDLES
• 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: 15988466
• Report Number: 9613304-2022-00010
• Device Sequence Number: 5950248
• Product Code: FMI
• UDI-Device Identifier: 05907996093052
• UDI-Public: (01)05907996093052(17)260901(10)B46ZE6
• 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
• Report Date (Section B): 11/17/2022

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: 09/01/2026
• Device Model Number: 31G X 8 MM
• Device Catalogue Number: 8309
• Device Lot Number: B46ZE6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2021
• 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