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U.S. Department of Health and Human Services

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

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BECTON DICKINSON VIAL ADAPTER Q-STYLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameVIAL ADAPTER Q-STYLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12487654
MDR Text Key272455265
Report NumberMW5104047
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number385108
Device Lot Number1053411
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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