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

Model Number 32G X 4 MM

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

Patient states that he is not getting the appropriate amount of insulin from his lantus solostar after starting to use the droplet pen needles 32g x 4mm.Previously the pt has used the bd pen needle 32g 4mm.

• Brand Name: DROPLET
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• Manufacturer Contact: aleksandra prazmowska -wilanowska ; adamowek 7; ozorkow 95-03-5 ; PL 95-035
• MDR Report Key: 9509318
• MDR Text Key: 198617219
• Report Number: 9613304-2019-00087
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K143437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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 Model Number: 32G X 4 MM
• Device Catalogue Number: 8315
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No
• 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