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 called because her pen needles are not dispensing the insulin properly.Customer states that some of her pen needles are not dispensing her insulin accurately.Customer did not seek any medical attention.

• 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: 12341627
• MDR Text Key: 267246093
• Report Number: 9613304-2021-00027
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00021292010317
• UDI-Public: (01)00021292010317(17)221001(10)X56ZA6
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 9052
• Device Lot Number: X56ZA6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2017
• 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