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

Model Number	234132
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.If product is returned, arkray will send to manufacturer for testing and file a follow-up report when evaluation is complete.
Event or Problem Description
Received email from customer.Contacted customer for follow-up and to gather more information.There was no needle at all on one of the pen needles.She has been injecting since (b)(6) 2018 so is not new to pen needles.She states that over 30 needles bent in use on the patient side of the needle.She is inserting at the 90-degree angle and then removing straight out.Part 234132.Lot z58f2 - 2024-05-01.Replaced devices and sent return label.

• 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: 9638541
• Report Number: 1832816-2020-00005
• Device Sequence Number: 19563980
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/03/2020

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: 05/01/2024
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Z58F2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1