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

Model Number	236132
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
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.10 pen needles from archival sample were tested with triple puncture into a silicone cube with a hardness of 55 shore (imitating the hardness of human tissue).No defects were observed during test.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 is stating that over the course of time she found defective needles in her techlite pen needle product.She is using lot number y46zp5, expiration 2023-12-01.Part 236132.She uses humalog kwik pens.She states that she is finding dull needles that will not go through her skin and some are coming in the packaging that are broken or crooked.Replaced devices 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: 9547411
• Report Number: 1832816-2020-00002
• Device Sequence Number: 2245944
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328
• 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): 12/11/2019

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: 12/01/2023
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: Y46ZP5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1