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	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.Dhrs were reviewed and no records confirming the defect were observed.Archival samples meet requirements of specification.10 pen needles from archival sample were randomly selected for testing.Pen needles from archival sample 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.The defect is not confirmed.Root cause analysis was not conducted.No capa initiated.If product involved in complaint is returned, arkray will send to manufacturer for testing and file a follow-up report when evaluation is complete.
Event or Problem Description
Customer says he places the pen needle on the pen, releases some of it to let out the air, and then places the pen needle in his skin.Most of the insulin is injected, but occasionally the flow of the insulin is compromised and not all of it comes out, and occasionally 10ml is left and will not come out.Caller states that 10-12 needles from the box has had this issue.Replaced devices and sent rl.
Additional Manufacturer Narrative
Customer returned complaint pen needles.The pen needle without the seal was visually inspected.Bent needle and damage on the inside of the hub were observed.They are characteristic to the marks left after incorrect assembly.User error, incorrect assembly.The defect is 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: 9921340
• Report Number: 1832816-2020-00010
• Device Sequence Number: 3257296
• 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): 04/06/2020

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: 10/01/2024
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Z58W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1