MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET; DROPLET PEN NEEDLE 32G X 4MM

Model Number N/A

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Samples form customer will be assessed if delivered.

Event Description

(b)(6) said, "2 out of every 10 needles doesn't work.I never had a problem until they changed the needles, and i know i'm not the only one.These foreign countries are ripping us off - the va can't afford this.It's a shame." medication is not flowing through the needle.He injects lantis silverstar 2x daily.

• Brand Name: DROPLET
• Type of Device: DROPLET PEN NEEDLE 32G X 4MM
• Manufacturer (Section D): HTL-STREFA S.A.; adamówek 7; 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: 8809612
• MDR Text Key: 151728065
• Report Number: 9613304-2019-00065
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 15907996093479
• UDI-Public: (01)15907996093479(17)231101(10)Y56ZJ4
• Combination Product (y/n): N
• PMA/PMN Number: K143437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/25/2019

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: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 8310
• Device Lot Number: Y56ZJ4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2018
• 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