MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE 32G X 6MM; PEN NEEDLES

Model Number 32G X 6MM

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

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Patient called on (b)(6) 2023 at 11:59 am.Patient received 3 boxes of droplet pen needles 32g x 6mm from baker's pharmacy with lot c56h8.Patient has used droplet pen needles in the past, and he has not had any issues.Patient claims that about 25%-50% of the pen needles are bending.Patient claims that he notices the bending both as he is trying to inject his insulin and when he is removing the pen needle from the skin.Patient has used about 28 needles of the lot number so far.Patient claims that some insulin will leak out of the skin, and that some insulin will stick to the insulin pen needle when removing it.Patient is unsure if he is receiving his full dosage of insulin, and he claims that his blood sugar has been higher than usual.Patient has not sought nor received medical attention for the issue, and as of now, he does not plan to.Patient injects 8-10 units of insulin 3 times per day using the novalog flexpen, and he injects 56 units of insulin once per day using the toujeo solostar pen.Patient claims that he is rotating injection sites, and that the needles are bending at each injection site that he selects.We are replacing the needles, and we are expecting samples.

Manufacturer Narrative

In the submitted notification, patient reported that many of the pen needles are bending.Additionally, some insulin will leak out of the skin, and that some insulin will stick to the insulin pen needle when removing it.Patient is unsure if he is receiving his full dosage of insulin, and he claims that his blood sugar has been higher than usual.We not received glycemia index.Patient has not sought nor received medical attention for the issue, and as of now, he does not plan to.However, the user as a diabetic patient self-monitor its blood glucose levels to proper glycaemic management.As per complaint description patient has used droplet pen needles in the past, and he has not had any issues.Nevertheless, we do not received detailed description of the injection technique, only information that patient is rotating injection sites, and that the needles are bending at each injection site that he selects.The complained defects were not confirmed in the internal evaluation of archival sample and device history records (dhr) review.Archival samples not confirmed any defects which could be the cause of the reported issues.Product involved in event was not returned to htl-strefa s.A.For further evaluation.As per notification, patient notices the bending both as he is trying to inject his insulin and when he is removing the pen needle from the skin.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.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) 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.To sum up, 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.

Manufacturer Narrative

In the submitted notification, patient reported that many of the pen needles are bending.Additionally, some insulin will leak out of the skin, and that some insulin will stick to the insulin pen needle when removing it.Patient is unsure if he is receiving his full dosage of insulin, and he claims that his blood sugar has been higher than usual.We not received glycemia index.Patient has not sought nor received medical attention for the issue, and as of now, he does not plan to.However, the user as a diabetic patient self-monitor its blood glucose levels to proper glycaemic management.As per complaint description patient has used droplet pen needles in the past, and he has not had any issues.Nevertheless, we do not received detailed description of the injection technique, only information that patient is rotating injection sites, and that the needles are bending at each injection site that he selects.The complained defects were not confirmed in the internal evaluation of archival sample and customer sample and device history records (dhr) review.Performed tests not confirmed any defects which could be the cause of the reported issues.As per notification, patient notices the bending both as he is trying to inject his insulin and when he is removing the pen needle from the skin.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.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) 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.To sum up, 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.Mdr 9613304-2023-00014 was submitted to fda, the follow up 1 was prepared due to customer sample evaluation.

Event Description

Patient called on (b)(6) 2023 at 11:59 am.Patient received 3 boxes of droplet pen needles 32g x 6mm from baker's pharmacy with lot c56h8.Patient has used droplet pen needles in the past, and he has not had any issues.Patient claims that about 25%-50% of the pen needles are bending.Patient claims that he notices the bending both as he is trying to inject his insulin and when he is removing the pen needle from the skin.Patient has used about 28 needles of the lot number so far.Patient claims that some insulin will leak out of the skin, and that some insulin will stick to the insulin pen needle when removing it.Patient is unsure if he is receiving his full dosage of insulin, and he claims that his blood sugar has been higher than usual.Patient has not sought nor received medical attention for the issue, and as of now, he does not plan to.Patient injects 8-10 units of insulin 3 times per day using the novalog flexpen, and he injects 56 units of insulin once per day using the toujeo solostar pen.Patient claims that he is rotating injection sites, and that the needles are bending at each injection site that he selects.We are replacing the needles, and we are expecting samples.Customer sample was returned to htl-strefa s.A.For further evaluation.Sample consist of pen needles under lot numbers: c56h8 and c56l1 (not mentioned in original notification).

• Brand Name: DROPLET PEN NEEDLE 32G X 6MM
• 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: 17243677
• MDR Text Key: 318495871
• Report Number: 9613304-2023-00014
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 05907996093090
• UDI-Public: (01)05907996093090(17)270401(10)C56H8
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 171982
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 32G X 6MM
• Device Catalogue Number: 8313
• Device Lot Number: C56H8, C56L1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male