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	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhrs were reviewed and no records confirming the defect were observed.Archival and returned samples meet requirements of specification.Additionally, 10 randomly selected pen needles from archival and returned 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.No further action.Complaint closed.
Event or Problem Description
Caller is using pen needles with victoza.Sometimes he puts one on and the insulin will not come out.The needle is not bent at all and he only uses them once.Part 234132.Replaced pen needles and sent 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: 8518617
• Report Number: 1832816-2019-00009
• Device Sequence Number: 11131270
• 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
• Report Date (Section B): 03/19/2019

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: 12/01/2022
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: X56ZH2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1