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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INTERLINK EXT 1 ADAPTER LINE

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BECTON DICKINSON INTERLINK EXT 1 ADAPTER LINE Back to Search Results
Catalog Number 2N3374-ZBA
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that leaked occurred from the interlink ext 1 adapter line connection.
 
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Brand NameINTERLINK EXT 1 ADAPTER LINE
Type of DeviceADAPTER LINE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8206874
MDR Text Key131908971
Report Number2243072-2018-01870
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2N3374-ZBA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/31/2018 Patient Sequence Number: 1
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