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

Model Number 32G X 6MM

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The customer is claiming that he is experiencing insulin flow issues.Of a box of 100 about 10 of the needles would not deliver insulin.

• Brand Name: TECHLITE
• 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: aleksandra prazmowska -wilanowska ; adamowek 7; ozorkow 95-03-5 ; PL 95-035
• MDR Report Key: 9509129
• MDR Text Key: 172450998
• Report Number: 9613304-2019-00086
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10015482236325
• UDI-Public: (01)10015482236325(17)240501(10)Z58E4
• Combination Product (y/n): N
• PMA/PMN Number: K143437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/21/2019

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
• Device Operator: No Information
• Device Expiration Date: 05/01/2024
• Device Model Number: 32G X 6MM
• Device Catalogue Number: 8646
• Device Lot Number: Z58E4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1