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

Model Number 31G X 8MM

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Manufacturer Narrative

In the submitted notification, there was reported difficulties with drug dose administration.Patient observed insulin leakage as the result of needle bending and was no able to complete all of his injections.Patient reports that his blood sugar has been much higher as a result of complained issues.Patient did not seek out or receive medical attention as a result of his high blood sugar, but he claims to have an appointment with his doctor soon where he intends to discuss the issue with the doctor.As per complaint description patient is experience in droplet brand, he should probably know the proper injection technique, but we not received detailed description.The complained defects were not confirmed in the internal evaluation of archival sample as per report (b)(4) and device history records (dhr) review.The issued lot number was complained for the first time.As we do not find the causal relationship between the serious incident and the device but due to adverse device experiences for user and because higher sugar level directly or indirectly, might have led or might lead to an acute complication of diabetes we decide to reportable event in country where the event was occurred.

Event Description

Patient called on 03/17/2023 at 1:51 pm and left a voicemail.Specialist was able to contact the patient on 03/20/2023 at 2:35 pm.Patient received 1 box of droplet pen needles 31g x 8mm from the va with lot number: b46e6.Patient has used droplet pen needles before and has not had any issues.Patient claims that many of the pen needles are bending as he attempts his stomach injection.He claims that the pen needles are bending at the base of the pen needle, closer to where the pen needle attaches to the insulin pen.Patient claims that, for the injections where the pen needle bends, roughly half of the insulin does not enter his body.Instead, it drips down the outside of his skin.Patient claims that he has not been able to complete all of his injections.Patient reports that his blood sugar has been much higher as a result.Patient attempted to speak to the pharmacy about this issue, and the pharmacy directed him to call htl.Patient has not seen his primary care physician since his pen needles started bending, but he claims to have an appointment with his doctor soon where he intends to discuss the issue with the doctor.Patient injects 4 times per day.Patient injects 3 times per day with the novalog flexpen and injects 18 units for the first injection and 20 units each for the other two.Patient also injects 50 units of lantus insulin once per day.Patient did not remember the name of the lantus pen.Patient injects on the left side of his stomach, but he is not injecting in the same spot each time.We are replacing the pen needles, but we are not expecting samples.

Manufacturer Narrative

In the submitted notification, there was reported difficulties with drug dose administration.Patient observed insulin leakage as the result of needle bending and was no able to complete all of his injections.Patient reports that his blood sugar has been much higher as a result of complained issues.Patient did not seek out or receive medical attention as a result of his high blood sugar, but he claims to have an appointment with his doctor soon where he intends to discuss the issue with the doctor.As per complaint description patient is experience in droplet brand, he should probably know the proper injection technique, but we not received detailed description.The complained defects were not confirmed in the internal evaluation of archival sample and customer sample as per report kj-pqt ar 128 23 810 rev.1 and device history records (dhr) review.The issued lot number was complained for the first time.As we do not find the causal relationship between the serious incident and the device but due to adverse device experiences for user and because higher sugar level directly or indirectly, might have led or might lead to an acute complication of diabetes we decide to reportable event in country where the event was occurred.The final recommendation of hhe team is: to report the event in us.Mdr 9613304-2023-00010 was submitted to fda, the follow up was prepared due to customer sample evaluation.

Event Description

Patient called on 03/17/2023 at 1:51 pm and left a voicemail.Specialist was able to contact the patient on 03/20/2023 at 2:35 pm.Patient received 1 box of droplet pen needles 31g x 8mm from the va with lot number: b46e6.Patient has used droplet pen needles before and has not had any issues.Patient claims that many of the pen needles are bending as he attempts his stomach injection.He claims that the pen needles are bending at the base of the pen needle, closer to where the pen needle attaches to the insulin pen.Patient claims that, for the injections where the pen needle bends, roughly half of the insulin does not enter his body.Instead, it drips down the outside of his skin.Patient claims that he has not been able to complete all of his injections.Patient reports that his blood sugar has been much higher as a result.Patient attempted to speak to the pharmacy about this issue, and the pharmacy directed him to call htl.Patient has not seen his primary care physician since his pen needles started bending, but he claims to have an appointment with his doctor soon where he intends to discuss the issue with the doctor.Patient injects 4 times per day.Patient injects 3 times per day with the novalog flexpen and injects 18 units for the first injection and 20 units each for the other two.Patient also injects 50 units of lantus insulin once per day.Patient did not remember the name of the lantus pen.Patient injects on the left side of his stomach, but he is not injecting in the same spot each time.We are replacing the pen needles, but we are not expecting samples.

• Brand Name: DROPLET PEN NEEDLES 31G X 8MM
• 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: 16774554
• MDR Text Key: 313641412
• Report Number: 9613304-2023-00010
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 05907996099405
• UDI-Public: (01)05907996099405(17)260301(10)B46E6
• 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,Followup
• Report Date: 03/20/2023

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: 31G X 8MM
• Device Catalogue Number: 7498
• Device Lot Number: B46E6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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: Male