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

Model Number	32G X 4MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint regarding insulin flow.The user claims that most of the insulin is injected, but sometimes the flow of the insulin is compromised, not all of it comes out, and occasionally 10ml is left and will not come out.Caller stated that 10-12 needles from the box had this issue.

• Brand Name: TECHLITE
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 9966365
• Report Number: 9613304-2020-00012
• Device Sequence Number: 14563441
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324(17)241001(10)Z58W3
• Combination Product (Y/N): N
• PMA/510(K) Number: K171982
• 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): 03/11/2020

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: No Information
• Device Expiration Date: 10/01/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: Z58W3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1