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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IV SET AN122 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON IV SET AN122 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 59011533
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. (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 the iv set an122 w/o pump t-type experienced foreign matter in the fluid pathway. The following information was provided by the initial reporter: foreign substances in tube.
 
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Brand NameIV SET AN122 W/O PUMP T-TYPE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12331941
MDR Text Key266936856
Report Number2243072-2021-02084
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number59011533
Device Lot Number2104233
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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