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	06/03/2020
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
Part 234132.Customer's daughter called because her mom's pen needles keep bending.She stated that she's had them for about two months or longer.Customer is not injecting in the scar tissue.She said she's twisting the pen needle onto the syringe properly.Customer stated she said she pinches the skin then injects straight into her skin.Verified she changes her needles with each injection.She doesn't use the same needle twice.Reviewed with the customer how to properly use the pen needle and confirmed she is doing everything correctly.Every other needle out of the box bends.Replaced devices and sent return 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: 10191162
• Report Number: 1832816-2020-00012
• Device Sequence Number: 3298018
• 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): 07/06/2020

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: 02/02/2025
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: A58C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1