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

Model Number	238931
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
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
Caller said needles are bending.She is using humalog kwikpen.The injection part is bending.She claims needle bends 30-20 degrees.8 mm x 31g (238931).She was using a 8 mm prior.She has been using our needles for about one month.The needle has bent about four times.Replaced product and sent rl.Possible malfunction that may cause improper dose or delay in treatment.
Additional Manufacturer Narrative
Product involved in incident was returned to arkay usa and forwarded to the manufacturer for evaluation.The manufacturer tested the returned devices, which performed to specification.Retain devices were also tested and performed to specification.Complaint unconfirmed, no failure detected.Manufacturer determined failure was due to the user not following the instruction for use.Because of user error associated with this device, the manufacturer will be implementing changes to the labeling which better explains the proper use of the product.

• 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: 7817737
• Report Number: 1832816-2018-00016
• Device Sequence Number: 14037535
• Product Code: FMI
• UDI-Device Identifier: 00015482238919
• UDI-Public: (01)00015482238919
• 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): 08/01/2018

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: 04/01/2022
• Device Model Number: 238931
• Device Catalogue Number: 238931
• Device Lot Number: X46ZL4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1