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

Model Number	32G X 4MM
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Lack of insulin flow, so needles are not working properly.Pen needles used with lantus i humalog quick pens.

• 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: 8563801
• Report Number: 9613304-2019-00051
• Device Sequence Number: 1981770
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324(17)190630(10)W46ZA5
• 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): 03/05/2019

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: 06/30/2019
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: W46ZA5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1