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

Model Number	31G X 5MM
Medical Device Problem Codes	Dull, Blunt (2407); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
User injects 54 units of levemere (each with the corresponding pen) 1x per day.He called in stating that these pen needle are dull and they don't inject his full dosage either.He has to use b/t 4-5 pen needles each time he injects.He does not reuse pen needle.
Event or Problem Description
User injects 54 units of levemere (each with the corresponding pen) 1x per day.He called in stating that these pen needle are dull and they don't inject his full dosage either.He has to use b/t 4-5 pen needles each time he injects.He does not reuse pen needle.
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on 2021-01-20 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.23.During testing, particular attention was paid to needle position on the non-patient end, needle patency and quality of needle blade.No deviations such as bent needles, dull needle, nonaxiality or others which could cause the defect under complaint were observed.No deviations were observed in the archival sample which could cause the defect under complaint - the product meets the requirements of product specifications.The pen needles have been broken and bend from non-patient end when the pen needle is incorrectly assembled onto the injection device which can cause problems with dosing drug.Evidence of improper winding is the characteristic bend of a broken cannula, matching the tip of the threaded pen, and marks on the inside of the hub of the pen needle.Additionally, before the destructive tests 10 randomly selected pen needles from the sample 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 and confirms the correctness of the pen needle assembly on the pen and the patency of the needles.Disassembly and verification of needles on the non-patient end also did not confirm the defect under complaint.In addition, the quality of the blades was checked in the samples provided from the customer.No deviations were found the most likely cause of the defect under complaint- problem with drug dose delivery is incorrect (non-axial or pushing for "click") of the pen needle on the pen injector device.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 11264635
• Report Number: 9613304-2021-00003
• Device Sequence Number: 4532728
• Product Code: FMI
• UDI-Device Identifier: 05907996092680
• UDI-Public: (01)05907996092680(17)250701(10)A46T9
• 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,Followup
• Report Date (Section B): 01/12/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2025
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8314
• Device Lot Number: A46T9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1