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

Model Number 31GX5MM

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/24/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 303293692
• Report Number: 9613304-2022-00006
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)250401(10)A56J1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female