MAUDE Adverse Event Report: DELTA HIGH TECH; INSULIN SYRINGE

Catalog Number 00502

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

User of syringes report that the needles are dull and do not have adequate silicon on them as well as the plunger.

Manufacturer Narrative

Qc reports investigated, lot 50451 soon to expire in 2 months, (b)(6) 2024.

• Brand Name: DELTA HIGH TECH
• Type of Device: INSULIN SYRINGE
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 18889247
• MDR Text Key: 337756182
• Report Number: 3001123929-2024-03166
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00502
• Device Lot Number: 50451
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1