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

Model Number	236132
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was returned to arkay usa and forwarded to the manufacturer for evaluation.The manufacturer tested the returned devices, which performed to specification.Retain devices were also tested and performed to specification.Complaint unconfirmed, no failure detected.Manufacturer determined failure was due to the user not following the instruction for use.Because of user error associated with this device, the manufacturer will be implementing changes to the labeling which better explains the proper use of the product.
Event or Problem Description
Part 236132.Customer stated that some of these needles are difficult to penetrate the skin and then if they can penetrate the skin, the patient hears a "pop" noise, and when the patient pushes the button to administer the insulin, only a little bit of insulin comes out and the proper dosage is not administered.Patient then tries another device until he's able to get the proper dosage of insulin.Caller stated that this last prescription there are a lot of needles in this box that are not working correctly.Patient has been using pen needles for a long time, and has been using techlite pen needles since (b)(6) 2018.Customer is doing injections in his belly.Replaced pen needles and sent rl.Lot x56p7 - 2022-06-01.
Additional Manufacturer Narrative
Updated investigation results were received from the manufacturer with new additional information.Arkray usa originally filed this mdr as an adverse event.The manufacturer classified as a malfunction.

• 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: 7768576
• Report Number: 1832816-2018-00014
• Device Sequence Number: 181894
• 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,Followup
• Report Date (Section B): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/01/2022
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: X56P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 70 YR