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	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in the incident was not returned for evaluation.Dhrs were reviewed.No records confirming the defect were observed.Drag force and penetration tests were completed on archival samples from same lot.10 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 archival 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.If complaint product is returned, arkray will send to manufacturer for testing and file a follow-up report when evaluation is complete.
Event or Problem Description
Customer stated that he just started using these pen needles last week.He said there's something wrong with the needles.He stated that the needle bends.He also said it hurts his finger and he's scared the needle will get stuck because it bends.He said the needles are incorrectly made and that he got a bad batch.He said he twists the needle on to the victoza.He said when he pulls the needle out of his testing site, he can see a few drops of insulin on the tip of the needle.He said he's pressing down to release it.He feels they are not as good as his other needles.He's using the side of his stomach and his outer thigh.Sometimes he pinches the area for his testing site.He is only using each needle once.He doesn't trust the needles.I did explain how to properly use the product.Replaced pen needles and sent rl.
Additional Manufacturer Narrative
Customer returned 73 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: 9139051
• Report Number: 1832816-2019-00023
• Device Sequence Number: 16876028
• 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: 02/01/2024
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Z46D3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/01/2019
• 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