MAUDE Adverse Event Report: BECTON DICKINSON VIAL ADAPTER Q-STYLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 385108

Device Problem Fluid/Blood Leak (1250)

Patient Problems Diarrhea (1811); Weight Changes (2607); Reaction to Medicinal Component of Device (4574)

Event Type  Injury  

Event Description

During solicited call with the patient, patient states she has been losing a lot of weight due to having diarrhea from the veletri.Patient states that her doctor is aware of this and they told the patient to take one-half tablet of imodium every 4 to 5 days.Patient says this helps manage the diarrhea very well.Patient says her doctor is aware of the weight loss as well and told the patient to keep her veletri dosing the same.Doctor told her to let them know if she starts having to take imodium more than every 4 to 5 days.Patient said that the last time she received vial adapter q-style from our pharmacy the adapters leaked every time she inserted them into the veletri vial and would tum the vial upside down to draw the medication out of the vial.The patient said enough medication came out that it would cover most of her hand.Lot number of adapters that were defective: 1053411, expiration date: 2/28/2026.Patient says she did not miss any doses of veletri and did not have any interruption in therapy due to this product issue.We are sending the pt new adapters to replace defective adapters.No further info available.Reported to (b)(6) by pt/caregiver.

• Brand Name: VIAL ADAPTER Q-STYLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12487654
• MDR Text Key: 272455265
• Report Number: MW5104047
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 385108
• Device Lot Number: 1053411
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1