MAUDE Adverse Event Report: HTL-STREFA S.A. TRUEPLUS, STERILE PEN NEEDLES

Model Number 32G X 4MM

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer state that the needle are no good.Customer states that the needles would just stop halfway when she tries to administer her insulin.The insulin would just stop half way.Verify customer is not using a compatible injector basaglar kwik pen.

• Brand Name: TRUEPLUS, STERILE PEN NEEDLES
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 12346501
• MDR Text Key: 267436700
• Report Number: 9613304-2021-00028
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00021292009076
• UDI-Public: (01)00021292009076(17)231201(10)Y58ZH8
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2023
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 9359
• Device Lot Number: Y58ZH8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1