MAUDE Adverse Event Report: MPS PHARMA & MEDICAL, INC. 7ML DROPPER BOTTLE STERILE; DISPENSER, LIQUID MEDICATION

Catalog Number AC211632-12

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

Inspecting product from mps pharma & medical cat.No: ac211632-12, lot m68406, a spec was noticed inside the 7ml dropper bottle.Spec was placed on a slide and reviewed, speck is a thrip (an insect).Several more bottles have been found with this in them.These are sterile packaged items with this insect in them.

• Brand Name: 7ML DROPPER BOTTLE STERILE
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): MPS PHARMA & MEDICAL, INC.; brea CA 92821
• MDR Report Key: 16911446
• MDR Text Key: 315115292
• Report Number: MW5117467
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2023

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 Catalogue Number: AC211632-12
• Device Lot Number: M68406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1