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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD MICROCLAVE® STABILIZED EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BECTON DICKINSON BD MICROCLAVE® STABILIZED EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 201-0016
Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/11/2023
Event Type  malfunction  
Event Description
This has been intermittently happening over the past week where the velanovascular ext stabilized extension set has a defect causing blood to pour out when it's hooked up to iv catheter upon initial insertion.Some other supplies were kept and provided to management , so i do not have those lot numbers, but today the packaging lot #9453943.I have been getting 2-3 devices doing this per day when i've been charging, with iv starts.Potential for safety issue as this exposes staff to blood unexpectedly and may cause malfunction of iv site requiring re-start.This particular patient was a very difficult iv start requiring iv us placement.Manufacturer response for set extension ext stabilized gen 2 201-0, (brand not provided) (per site reporter).Emailed vendor - no response yet.
 
Event Description
This has been intermittently happening over the past week where the velanovascular ext stabilized extension set has a defect causing blood to pour out when it's hooked up to iv catheter upon initial insertion.Some other supplies were kept and provided to management , so i do not have those lot numbers, but today the packaging lot #9453943.I have been getting 2-3 devices doing this per day when i've been charging, with iv starts.Potential for safety issue as this exposes staff to blood unexpectedly and may cause malfunction of iv site requiring re-start.This particular patient was a very difficult iv start requiring iv us placement.Manufacturer response for set extension ext stabilized gen 2 201-0, (brand not provided) (per site reporter) emailed vendor - no response yet.
 
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Brand Name
BD MICROCLAVE® STABILIZED EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON
1 becton dr
franklin lakes NJ 07417
MDR Report Key17236866
MDR Text Key318214935
Report Number17236866
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number201-0016
Device Lot Number9453943
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2023
Event Location Hospital
Date Report to Manufacturer06/30/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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