MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLES

Model Number 31 G X 8 MM

Device Problems Material Fragmentation (1261); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

Htl inc received an email complaint on (b)(6), 2023 at 3:56 am.From the initial complaint email: "i'm writing to your company,to complain about your droplet pen needles.Their not very sturdy, several times i try to get a needle in me, for my insulin intake, the needle bends, & a few even broke on me.I've wasted insulin due to your product being poorly made.They cost 54$ a box.For that price, they need to be more stronger than they are." we have reached out to the customer on (b)(6), 2023 at 9:32 am, and we are currently waiting for a response.The patient wrote back: droplet pen needles medical device droplicon 0.25mmx8mm 31gx5/16".Lot #0344 novolog 2 times daily & basaglar 2 times daily.Recieved from rite- aid pharmacy in needles ca.# of boxes bought -3.Injecting into the belly area always.Use 4 needles per day.Have used product for 4 years now, but just recently starting having problems with the product.I don't reuse them.Not able to complete the injection all the time.Needles have even broken off in the skin at times." on monday, (b)(6) 2023, i asked them again about the lot number and whether they needed medical intervention or not.I haven't gotten a response yet.We reached out again on friday, (b)(6) 2023, but we're still waiting for a response.Htl-strefa made several attemps to obtain addintional information about event and lot number, with no result.Provided number: "0344" - it is ce mark number, not lot number.

Manufacturer Narrative

In submitted notification, patient used product for 4 years, but recently starting having problems with needle bending and even broken off in the skin.Additionally, patient reported that he is not able to complete the injection.There was no information about serious injury or patient's health deterioration due event.Htl-strefa s.A.Made multiple attempts to interview with the patient and reach additional information with no result.Therefore, we have no lot number identification and no detailed description of injection technique.Only information, that patient injecting into the belly area always, use 4 needles per day, and don't reuse the needles.History of previous, similar events show that a level of confirmed defects of product in comparison to quantity sold is negligible, the ratio of the confirmed complaints is on very low level.Due to lack of lot number, there are no possibility to conduct the internal evaluation, confirm the defect and review the device history records.Product involved in event was not available.As per notification, patient experience needle bending during the injection.In the instruction of use added to every product box is helpful information how to make injection in proper way to prevent bending needle: make the injection as directed by your healthcare professional, do not bend the needle.Inject slowly.Do not withdraw the needle immediately after injection.Do not change the direction of the pen needle while it remains in the body as this can result in bending or breaking of the needle.We have no information about necessity of medical or surgical intervention due needle broken in the patient skin, and no information if patient plan to consult with health care professional.Additionally, no adverse health consequences have been reported due fact, that patient was not able to complete the injection.Insulin doses are closely correlated with the patient's condition and glycaemic control.Whether the patient has received adequate doses of inulin can be assessed throughout the day during glucose measurements.Considering the above, the administration of insulin is not indifferent (glucose monitoring, pain) to the patient and cannot be overlooked.Concerns about the administration of a full or incomplete dose of insulin are monitored by patients on an ongoing basis, therefore the risk of serious health complications is low.Glycaemic control is the main measure of diabetic status assessment and is an important parameter of daily therapy.However, the complained problems can be considered as the product malfunction, because needles had failures in regards of meet the performance specifications which caused adverse device experiences for user.

• Brand Name: DROPLET PEN NEEDLES
• Type of Device: 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: 17276903
• MDR Text Key: 318701984
• Report Number: 9613304-2023-00016
• Device Sequence Number: 1
• Product Code: FMI
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 31 G X 8 MM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female