MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLES 32G X 5MM

Model Number	32G X 5MM
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Fragmentation (1261)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called on (b)(6) 2023 at 3:55 pm.Patient received 1 box of droplet pen needles 32g x 5mm from stop and shop pharmacy with lot number: c46e5.Patient is new to the droplet brand, but she has been injecting insulin for roughly 30 years, and she has not experienced any similar problems before.Patient claims that, of 7 pen needles that she tried, a couple of the pen needles did not pierce her skin easily.Instead, she needed to push on the insulin pen with excessive force in order for the pen needle to penetrate the skin.Those pen needles also bent as she used more force to push the needle into her skin.Post-injection, she claims that some insulin would be on the surface of her skin rather than inside of the skin, making it difficult to tell if she had received her full does of insulin or not.The pen needles also left bruises on her skin.One pen needle broke off inside of her abdomen.The patient then used a razor blade to make an incision in her skin and use tweezers to retrieve the needle.Patient did not seek or receive medical attention, and she does not plan to do so.Specialist asked the patient to inform him if she decides to seek medical attention or if she experiences other adverse health effects.Specialist verified that her injection technique appears to be correct.Patient acknowledges that she had received the droplet instructions for use.Patient did not get counsel from the pharmacist when she purchased the pen needles.Patient injects into her abdomen.She injects "straight-on" and not at an angle.Patient claims to be rotating injection sites.Patient injects twice a day using the novalog 70/30 insulin pen.Patient injects 30 units in the morning and 25 units before going to bed.Patient has included an image of the bruises on her abdomen caused by using droplet pen needles.We are replacing the needles, and we are expecting samples.A per additional information: "the patient never mentioned any unsafe blood sugar levels or other health consequences due to incomplete injections.She mentioned that she received some pen needles of another brand from her pharmacy after this incident- and used those for her injections.However, i'm not sure if she completed all of her scheduled injections before receiving those other pen needles.".

• Brand Name: DROPLET PEN NEEDLES 32G X 5MM
• 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: 16751268
• Report Number: 9613304-2023-00009
• Device Sequence Number: 20971484
• Product Code: FMI
• UDI-Device Identifier: 05907996092680
• UDI-Public: (01)05907996092680(17)270301(10)C46E5
• 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): 03/16/2023

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: 03/01/2023
• Device Model Number: 32G X 5MM
• Device Catalogue Number: 8314
• Device Lot Number: C46E5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female