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

Model Number	32G X 6MM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tests on archival sample were performed on (b)(6) 2018 for compliance with the parameters established in product specifications.There were performed tests to measure the penetration force and drag force for the needle.No nonconformities were found.Ten pen needles from archival sample were tested by puncturing into the silicone cube with the hardness of 55 shore (imitating the hardness of human tissue).No hooks occurred.No bending of the needle occurred.The test of priming the pen needle was performed for 10 pen needles from archival sample.Test consisted of assembly the pen needle onto the pen injector, setting the dose of 2 units and pushing the button.No defects or other nonconformities were found.For all pen needles a flow of fluid was observed.On 2018-07-25 htl-strefa (b)(4) received the sample from customer.The tests were performed on 2018-07-26 for compliance with the parameters established in product specifications.The defects under complaint were not confirmed in the sample from customer.Additional test were performed to measure the penetration force and drag force for the needle.No nonconformities were found.Additionally, 10 pen needles from sample from customer were tested by puncturing into the silicone cube with the hardness of 55 shore (imitating the hardness of human tissue).No hooks occurred.No bending of the needle occurred.The test of priming the pen needle was performed for 10 pen needles from sample from customer.Test consisted of assembly the pen needle onto the pen injector, setting the dose of 2 units and pushing the button.No defects or other nonconformities were found.For all pen needles a flow of fluid was observed.
Event or Problem Description
The customer is claiming that the needles do not release insulin the way they should and that the don't penetrate the skin well.Customer stated that same of these needles are difficult to penetrate the skin and then if they can penetrate the skin, the patient hears a "pop" noise, and when the patient pushes the button to administer the insulin, only a little bit of insulin comes out and the proper dosage is not administered.Patient then tries another device until he's able to get the proper dose of insulin.Caller stated that this last prescription there are a lot of needles in this box that are not working correctly.Customer is doing injections in his belly.

• Brand Name: TECHLITE PEN NEEDLE
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 7775999
• Report Number: 9613304-2018-00004
• Device Sequence Number: 13706175
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328(17)220601(10)X56P7
• 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): 07/13/2018

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: 06/01/2022
• Device Model Number: 32G X 6MM
• Device Catalogue Number: 8648
• Device Lot Number: X56P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1