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

Model Number	234132
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.Dhrs were reviewed and no records confirming the defect were observed.Archival samples meet requirements of specification.Additionally, 10 randomly selected pen needles from archival samples were assembled on pen injector.With every attempt, droplets on the cannula were observed and injection of applied dosage can be seen which confirms the correctness of the pen needle assembly on the pen and the patency of the needles.The defect is not confirmed.Root cause analysis was not conducted.No capa initiated.If product involved in complaint is returned, arkray will send to manufacturer for testing and file a follow-up report when evaluation is complete.
Event or Problem Description
Customer can get the pen needle on the device.When she's priming, only a small amount of insulin comes out, and she would try again and only a little liquid would come out, so she would grab another pen needle and it would work fine.Customer is needing to use numerous devices to get the proper amount of insulin.Asked if the needle was bent and she confirmed that the needles are not bent.Asked if there was damage to the package and there was no damage to the packaging.Part 234132.Lot z58f3 - 2024-01-05 - 100ct.Replaced devices and sent return label.
Additional Manufacturer Narrative
Customer returned 29 pen needles.On 10 returned pen needles, the needle patency was checked under a microscope by observing light passing through the lumen of the cannula.10 returned pen needles were then assembled on the pen injector.With every assembly attempt, droplets on the cannula were observed and injection of the applied dosage can be seen which confirms the correctness of the pen needle assembly on the pen and the patency of the needles.Fluid flow was obtained in all tested pen needles.No defects under complaint were observed.Root cause analysis was not conducted.No capa initiated.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-035 ozorkow; PL
• MDR Report Key: 9473193
• Report Number: 1832816-2019-00032
• Device Sequence Number: 16792586
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 01/05/2024
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Z58F3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1