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	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was returned for evaluation and forwarded to the manufacturer for further evaluation.Evaluation results are pending.Arkray will file a follow-up report when evaluation is complete.
Event or Problem Description
Customer just started using our products and he is having issues with getting the needle into his skin and sometimes bending.He has three boxes and has only used about 8 of them so far and has been an issue with each needle.Caller doesn't use same injection site.Caller has no scar tissue and not injecting into navel.Never reuses needles.Part 234132.Replacing two boxes and sending label.
Additional Manufacturer Narrative
Customer returned complaint pen needles.Retain samples and returned samples were tested.Drag force and penetration tests were performed on retain samples and results were in specification range.The defect was not confirmed.Puncture tests and microscopic analysis was performed on returned samples.The defect was not confirmed.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: 10066501
• Report Number: 1832816-2020-00011
• Device Sequence Number: 11686616
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• 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): 05/04/2020

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: 11/01/2024
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Z58W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1