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

Model Number	238131
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
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 is using the techlite pen needles and have been using the brand for one year.He stated when he puts the pen needle on to his lantus, it doesn't pierce the device right away and causes the needle to bend.He is using part (b)(4).Verified that the customer is not re-using the pen needle.It is bending on the first use.He is stating that it's very difficult to get the needle on to the lantus.They must apply pressure.
Additional Manufacturer Narrative
Dhrs were reviewed and no records confirming the defect were observed.Archival and returned samples meet requirements of specification.Additionally, 10 randomly selected pen needles from archival and 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.Defect was not confirmed.Root cause analysis was not conducted.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: 8206134
• Report Number: 1832816-2018-00025
• Device Sequence Number: 16634351
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315
• 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): 01/03/2019

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: 08/31/2019
• Device Model Number: 238131
• Device Catalogue Number: 238131
• Device Lot Number: W46ZE9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1