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

Model Number	31G X 5MM
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of the archival sample was conducted on 2018-03-09 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.14.No deviations were observed in the archival sample which could cause the defect under complaint.Htl is not in possession of levemir flextouch pen which was indicated by the patient.Testing was conducted on tresiba flex touch (prefilled pen).The devices only differ in the type of insulin.A pen needle was attached onto the pen injector, (b)(4) units were set and injection was simulated.After the test, the preset dose of insulin flow was observed and the device returned to 0 setting.The test was conducted on 10 pen needles under complaint.Correct fluid flow was observed for each pen needle.The sample under complaint from customer was returned on 2018-03-15.Testing of (b)(4) pen needles from the shelf box was conducted on (b)(6) 2018 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.14.No deviations were observed in the sample which could cause the defect under complaint.The product meets the requirements of specifications.Additional tests: additional tests were conducted on the 23 complete pen needles packed in a zip bag.The aim of the test was to simulate an injection made by the patient.Pen needle lot x46zm6, returned from the customer was attached to tresiba flex touch pen, (b)(4) units were set and an injection was simulated.No deviations were observed in any of the 23 tests.After the test, the preset dose of insulin flow was observed and the device returned to 0 setting.
Event or Problem Description
Mr.(b)(6) is a veteran and gets his supplies from the va.He was switched from easytouch to droplet, same size.He started using droplet and started having trouble dispensing the full dose.He has been a diabetic for the last 7 years.He slightly pinches up and dispenses the pen.It stops when he has about 4 units left.With the issues, mr.(b)(6) had his wife, a nurse, try to inject him and she had the same issues.

• Brand Name: DROPLET, PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 7368936
• Report Number: 9613304-2018-00002
• Device Sequence Number: 13462087
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)221201(10)X46ZM6
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 12/01/2022
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8310
• Device Lot Number: X46ZM6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1