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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. OBTURATOR FOR VENFLON/SAFELON1.0X32 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. OBTURATOR FOR VENFLON/SAFELON1.0X32 INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 394252
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/31/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the obturator for venflon/safelon1. 0x32 was delivered without a label. This was noticed prior to use. The following information was provided by the initial reporter, translated from german to english: "one packaging unit of the ref 394252 was delivered without labels, lot number 9200654. ".
 
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Brand NameOBTURATOR FOR VENFLON/SAFELON1.0X32
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10571045
MDR Text Key208776915
Report Number1710034-2020-00606
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394252
Device Lot Number9200654
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2019
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: 09/22/2020 Patient Sequence Number: 1
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