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

Model Number	238131
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was returned for evaluation.Dhrs were reviewed and no records confirming the defect were observed.In both archival and returned samples, all pen needles were straight and complete.Nonconformities that could cause the defect were not observed.The defect is not confirmed.Root cause analysis was not conducted.No capa initiated.
Event or Problem Description
Customer called because he has had about 12 pen needles that were bent after removing the safety cap.The needles weren't used, they were brand new.He said the needles were bent at a 90-degree angle.He disposed of them in his sharp's container.He's had the pen needles for about one week.He believes there is a manufacturer defect.Customer is using novolog and basaglar kwik pens.Verified that he is placing the pen needle on his insulin pen, twisting it, then removing the clear top by pulling it.He also noticed that the blue safety cap wasn't there to cover the needle.He stated the clear cap was the only cover on the pen needles.Walked customer through checking a pen needle and both safety caps were visible, and the needle wasn't bent.Lot z56w2 - 2024-10-01.Product 238131.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: 9841279
• Report Number: 1832816-2020-00008
• Device Sequence Number: 14174771
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315
• 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
• Report Date (Section B): 02/21/2020

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: 10/01/2024
• Device Model Number: 238131
• Device Catalogue Number: 238131
• Device Lot Number: Z56W2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1