MAUDE Adverse Event Report: PHARMACY LITE PACKAGING 33MM GREEN EZ ONE VIALS; CONTAINER, LIQUID MEDICATION GRADUATED

Model Number GEZ-150

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

Event Description

We had a parent of an individual that we fill liquid prescription for bring up an issue they were having with the gez-150 bottles that we dispense the liquid preparation in.We typically do 360ml of this particular suspension in each gez-150 bottle.The parent's complaint was that on two separate occasions, once when the bottle was nearly full and once when it was about 1/4 full, when they are drawing a dose out of the bottle they happened to drop the vial on the laminate floor in their home and the bottle shattered (not just cracked but shattered producing pieces of plastic).They estimate a 5 ft fall height, bottles being stored refrigerated (35-45 degrees fahrenheit - nothing frozen) and dose being taken out immediately after shaking suspension while the bottle is still cold.A majority of our products that we dispense in these bottles require refrigeration, and though dropping a bottle is not an ideal situation, should they not stand up to that kind of impact? is this a part of the company's quality control process for these bottles? is there something regarding the plastic's chemical make up of the particular batches that we received? we were a little skeptical at first, but then we tried it in our pharmacy.We filled a bottle full of water (which may potentially be lighter than the suspension) and simulated the situation at both room temperature and refrigerated (35-45 degrees f).The bottle held up to the impact at room temperature, but when cold the bottle broke open near the base and produced plastic shards.We have purchased a total of 6 boxes, with 4 full boxes on hand and one currently in use.Emphasis on bottle being cold and breaking if dropped.Fda safety report id # (b)(4).

• Brand Name: 33MM GREEN EZ ONE VIALS
• Type of Device: CONTAINER, LIQUID MEDICATION GRADUATED
• Manufacturer (Section D): PHARMACY LITE PACKAGING
• MDR Report Key: 8611952
• MDR Text Key: 145486015
• Report Number: MW5086634
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GEZ-150
• Device Catalogue Number: 0222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR