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	05/10/2019
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
Caller is calling to complain that the needles are bending in the process of doing the injection and he must push the plunger very hard to get his full dose of insulin.He is using the lilly humalog pen.Customer only uses the needles once.Size is 100ct 0.23 x 4mm 32g.He said that it has happened with multiple boxes of needles.Part 234132.Lot y58zc9 - 2023-10-01.Replaced devices and sent rl.(b)(4).
Additional Manufacturer Narrative
Dhrs were reviewed and no records confirming the defect were observed.On both archival and returned samples, drag force and penetration force were measured.Samples meet requirements of specification.On both archival samples (10) and returned samples (6), pen needles from each sample were puncture tested into a silicone rubber cube with a hardness of 55 shore imitating human tissue.No defects observed.On both archival samples (10) and returned samples (6), pen needles were assembled onto pen injector.With every assembly attempt, droplets on the cannula were observed and inject of the applied does can be seen which confirms the correctness of the pen needle assembly and the patency of the needles.Fluid flow was obtained in all pen needles.No defects observed.No corrective action.Complaint closed.

• 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: 8667623
• Report Number: 1832816-2019-00010
• Device Sequence Number: 2169448
• 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): 06/11/2019

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: 10/01/2023
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: Y58ZC9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1