MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLES

Model Number	31G X 8MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
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 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.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8330234
• Report Number: 9613304-2019-00027
• Device Sequence Number: 1064437
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315(17)230701(10)Y46ZA5
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 07/01/2023
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8646
• Device Lot Number: Y46ZA5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1