MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET 31GX5MM PEN NEEDLE

Model Number	31GX5MM
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, the needle broke off in pateints abdomen, my husband needed a flash light and tweezers to removed it.I open one days ago and the needle was already bent.These needles are short and tiny, i did not know i would be taking a risk causing harm from them breaking off in my body and/ or bending.This is not the first time she has been injured by our product.She has used the product for years without incident but with this lot no.She has experienced the needle break as described above, a needle stick due to the pn being bent on the patient end and being exposed through the cap, and recently she experienced the pn bending into her abdomen but, not actually breaking off.With the pn stick that did break off, there was no blood and husband was able to fully remove it so medical attn.

• Brand Name: DROPLET 31GX5MM PEN NEEDLE
• 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: 14797831
• Report Number: 9613304-2022-00006
• Device Sequence Number: 5057842
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)250401(10)A56J1
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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: 04/01/2025
• Device Model Number: 31GX5MM
• Device Catalogue Number: 8310
• Device Lot Number: A56J1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• 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