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

Model Number	32G X 4MM
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 12341627
• Report Number: 9613304-2021-00027
• Device Sequence Number: 3737028
• Product Code: FMI
• UDI-Device Identifier: 00021292010317
• UDI-Public: (01)00021292010317(17)221001(10)X56ZA6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1