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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD GRAVITY IV SET WITH 3-PORT CLOSED MANIFOLD INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON BD GRAVITY IV SET WITH 3-PORT CLOSED MANIFOLD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number CM42500E-07
Device Problems Separation Failure (2547); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number. Medical 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.
 
Event Description
It was reported that 10 bd¿ gravity iv sets with 3-port closed manifold disconnected during use. The following information was provided by the initial reporter: "we are having issues with the new bd gravity iv w/ 3-port tubing sets, ref# (b)(4). They are disconnecting and popping off. Reported this happening with 10 patients yesterday. While speaking with the team, they mentioned they are tightening every single set they get. We didn't have this issue with our previous tubing. ".
 
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Brand NameBD GRAVITY IV SET WITH 3-PORT CLOSED MANIFOLD
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12511850
MDR Text Key272679602
Report Number2243072-2021-02361
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberCM42500E-07
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? No
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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