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

Model Number	236132
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
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
Customer has techlite pen needles, part 236132.Lot x56p7.Caller says that the needles bend when he injects his insulin.I tried to advise on how to use pen needles since he just got switched to our brand.Customer is not satisfied with quality of product and wants refund.Advised refund will need to come from pharmacy.I suggest we replace the box and send him out a new box to try out.Customer seems to want to be switched to old brand.I advised insurance will have to take care of that.Replaced pen needles and sent return label.Advised on how to return product.
Additional Manufacturer Narrative
Dhrs were reviewed.No records confirming the defect were observed.10 pen needles from archival sample were tested with triple puncture into a silicone cube with a hardness of 55 shore (imitating the hardness of human tissue).No defects were observed during test.Additionally, 10 pen needles from returned sample were tested with triple puncture into a silicone cube with a hardness of 55 shore (imitating the hardness of human tissue).No defects were observed during test.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: 8340476
• Report Number: 1832816-2019-00002
• Device Sequence Number: 18883687
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/28/2019

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: 06/01/2022
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: X56P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1