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	01/08/2019
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.Dhrs were reviewed.No records confirming the defect were observed.Drag force and penetration tests were completed on archival samples from same lot.Ten pen needles were tested with triple puncture test into a silicone cube with a hardness of 55 shore, imitating human skin hardness.No defects under complaint were observed.Drag force and penetration tests were completed on returned samples.Ten pen needles were tested with triple puncture test into a silicone cube with a hardness of 55 shore, imitating human skin hardness.No defects under complaint were observed.Root cause analysis was not conducted.No corrective action.Complaint closed.
Event or Problem Description
Customer is using the 8mm - 31-gauge needles and some of them he claims are bent.They are fine when he opens them but when he tries to inject the insulin then he isn't getting any medication.He has been using these since july without any incident, so they are implying that there's something wrong with the needle.They're trying to say that when he is trying to insert the needle in his skin then that's when the needle bends and he is not able to inject.They are using his stomach and there is no scarring that may make it difficult to insert or cause bending.This has happed to about 3-4 times and they have about 90 devices left in the box.It does prime before inserting needle into skin.Apparently, the needle is not penetrating the skin at all and just bends.They feel that perhaps the needle isn't sharp enough.Part 238131.

• 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: 8307123
• Report Number: 1832816-2019-00001
• Device Sequence Number: 16158857
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Model Number: 238131
• Device Catalogue Number: 238131
• Device Lot Number: Y46ZA5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1