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	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in the incident was returned to arkray usa and forwarded to the manufacturer 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.Fluid flow was obtained in all tested pen needles.Returned samples meet requirements of specification.Additionally, returned pen needles 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.Fluid flow was obtained in all tested pen needles.The defect is not confirmed.Root cause analysis was not conducted.No capa initiated.No further action.Complaint closed.
Event or Problem Description
Customer is using techlite pen needles.Lot y58j3 - 32 guage x 4 mm - 100ct.Part 234132.He is using a "basaglar" pen that he states is made by lily kwikpen.He states the injection is not "smooth" and insulin leaks from the side.He does not believe that the techlite pen needles are compatible with this pen, but our advertising states it should be.Informed customer we can replace his pen needles and can try them with his kwik pen.Informed product will arrive in 3 to 5 business days.Gave instructions to send product back with return label.Please replace pen needles and send rl.

• 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: 8827291
• Report Number: 1832816-2019-00013
• Device Sequence Number: 226304
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/02/2019

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: 03/01/2012
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Y58J3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1