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

Model Number	234132
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in the incident was returned to arkray usa and forwarded to the manufacturer for evaluation.We have not yet received evaluation results.Arkray will file a follow-up report when device evaluation is complete.
Event or Problem Description
Customer reported that the replacement devices from his original complaint call on (b)(6) 2019 are not working any better than the complaint devices he originally reported on (b)(6) 2019.Today he stated that he has had to use five or six different pen needles to properly inject his insulin.He claimed that the needles feel dull or blunt when inserting into the skin and are very painful and that the flow of insulin is not good, and he had one get "clogged" today when attempting to inject the insulin.Customer stated he only uses the pen needles once and is not attempting to reuse them.He stated he does not have issues putting the pen needle on the pen.Lot z58f3, expiration 2024-05-01.Part 234132.Replaced product and sent return label.
Additional Manufacturer Narrative
Customer returned 85 pen needles.Drag force and penetration force were measured and results were with the specification range.10 returned pen needles were tested with triple puncture test into a silicone cube with a hardness of 55 shore, imitating human skin hardness.Additionally, 10 randomly selected pen needles from returned samples were assembled on pen injector.With every attempt, droplets on the cannula were observed and injection of applied dosage can be seen which confirms the correctness of the pen needle assembly on the pen and the patency of the needles.Fluid flow was obtained in all tested pen needles.No defects under complaint were observed.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: 9187316
• Report Number: 1832816-2019-00024
• Device Sequence Number: 2597449
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• 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): 11/26/2019

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: Z58F3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1