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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTERVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD INTERVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that 10 unspecified bd intervascular administration sets experienced device damage/deformation.The patient experienced an infection as a result of the defect.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter: rn drawing cultures, went to hook patient back up to line and end connection of trifuse (side that connects to patient) cracked.Rn replaced cap again on patient and replaced trifuse.Rn drawing cultures after patient's fever and vital signs triggered a sepsis alert.Upon disconnecting the patient's line from her picc, rn noted that the bifuse connector was cracked at the clave that connects directly to the patient's picc line.When rn removed bifuse from patient's other line, rn felt the same connector crack as she tried to disconnect it.Rn had to replace both bifuses after cultures were drawn.Patient's labs later revealed clabsi.When rn unhooked tri-fuse from patient's clave in order to draw cultures, the tri-fuse came off cracked in rn's hand.Rn had to replace tri-fuse.This is the second night in a row that this has happened to the same patient in the same situation.When rn unhooked quad-fuse from patients clave in order to draw cultures, the quad-fuse came off cracked in rn hand.Rn had to replace quad-fuse.Rn drawing cultures; when rn went to hook back up the line to needless connector, the quad-fuse luer lock (male connector) broke/snapped off.Patient stated to rn that this has happened multiple times before.Quad fuse changed.When removing tri-fuse from patient's ivf line rn noticed that connecting portion of tri fuse was cracked.Rn gave faulty equipment to cns on floor rn removed quad-fuse from patient's clave when drawing cultures.When rn went to rehook up quad-fuse to patient, clave on quad-fuse that connects to patient cracked for both lumens.Rn had to replace quad-fuse.Trifuse cracked while continuous chemo was running.
 
Event Description
It was reported that 10 unspecified bd intervascular administration sets experienced device damage/deformation.The patient experienced an infection as a result of the defect.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter: rn drawing cultures, went to hook patient back up to line and end connection of trifuse (side that connects to patient) cracked.Rn replaced cap again on patient and replaced trifuse.Rn drawing cultures after patient's fever and vital signs triggered a sepsis alert.Upon disconnecting the patient's line from her picc, rn noted that the bifuse connector was cracked at the clave that connects directly to the patient's picc line.When rn removed bifuse from patient's other line, rn felt the same connector crack as she tried to disconnect it.Rn had to replace both bifuses after cultures were drawn.Patient's labs later revealed clabsi.When rn unhooked tri-fuse from patient's clave in order to draw cultures, the tri-fuse came off cracked in rn's hand.Rn had to replace tri-fuse.This is the second night in a row that this has happened to the same patient in the same situation.When rn unhooked quad-fuse from patients clave in order to draw cultures, the quad-fuse came off cracked in rn hand.Rn had to replace quad-fuse.Rn drawing cultures; when rn went to hook back up the line to needless connector, the quad-fuse luer lock (male connector) broke/snapped off.Patient stated to rn that this has happened multiple times before.Quad fuse changed.When removing tri-fuse from patient's ivf line rn noticed that connecting portion of tri fuse was cracked.Rn gave faulty equipment to cns on floor rn removed quad-fuse from patient's clave when drawing cultures.When rn went to rehook up quad-fuse to patient, clave on quad-fuse that connects to patient cracked for both lumens.Rn had to replace quad-fuse.Trifuse cracked while continuous chemo was running.
 
Manufacturer Narrative
Investigation: no product or photo was returned by the customer.The customer complaint of connector cracked and luer lock brake could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed because a valid lot number was not provided by the customer.H3 other text : see h.10.
 
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Brand Name
UNSPECIFIED BD INTERVASCULAR ADMINISTRATION SET
Type of Device
INTERVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11103426
MDR Text Key229843993
Report Number2243072-2020-02267
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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