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

Model Number 32G X 6MM

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The patient called in stating that his droplet pen needle 32g x 6mm is are not dispensing insulin.We asked several probing questions to find out about his injection technique, area of the body, pn reuse, if there was bending/breaking etc; however, he kept repeating himself stating that the insulin won't come out.Customer grew a bit irritated because, he felt like i did not understand his issue due to language barrier.This is his 1st time using droplet.He normally uses a different brand but, cannot recall the name of it.

Manufacturer Narrative

Analysis of the archival sample was conducted on 2021-09-30 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.22.The analysis of customer sample was conducted on 2021-09-24 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.22.No deviations were observed in the archival sample and sample from customer which could cause the defect under complaint - the product meets the requirements of product specifications.Additionally, before the destructive tests 10 randomly selected pen needles from the archival sample and sample from customer were assembled on the pen injector.With every assembly attempt, droplets on the cannula were observed and injection of the applied dose can be seen, which is visible on the paper.As per notification, patient did not wish to provide additional information about his injection technique, area of the body, pn reuse, if there was bending/breaking etc.However, the complained issues could be related to unappropriated technique of insulin delivery or reuse of the needles.Additionally, patient state that it was 1st time of using droplet, problem could be related to misuse of pen needle.

Event Description

The patient called in stating that his droplet pen needle 32g x 6mm is are not dispensing insulin.We asked several probing questions to find out about his injection technique, area of the body, pn reuse, if there was bending/breaking etc; however, he kept repeating himself stating that the insulin won't come out.Customer grew a bit irritated because, he felt like i did not understand his issue due to language barrier.This is his 1st time using droplet.He normally uses a different brand but, cannot recall the name of it.

• Brand Name: DROPLET PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 12346589
• MDR Text Key: 267440430
• Report Number: 9613304-2021-00029
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K171982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

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: 32G X 6MM
• Device Catalogue Number: 8313
• Device Lot Number: A46P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1