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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 14-IN MINIBORE SET W/MAXPLUS INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON 14-IN MINIBORE SET W/MAXPLUS INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MP9236-C
Device Problems Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
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. Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number. 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.
 
Event Description
It was reported that 14-in minibore set w/maxplus experienced a case of luer-lok collar breakage and difficulty disconnecting device. The following information was provided by the initial reporter: material no: mp9236-c batch no: 20036437 we communicated in 2018 regarding the extensions used. Recently we had an incident where the plastic of the extension connector broke off and got lodged into the picc line port. The physician had to remove the picc line. Staff have verbalized they have been having problems with removing the extensions (either the thread is gone or its on too tight). The extension im talking about is the bd maxplus extension set (minibore) with clear needleless connector (ref# mp9236-c). In the department i work in we have been supplied the maxplus extension set. The staff have verbalized they have had issues with the tubing getting stuck and making it difficult to remove. But the tube braking off was the first time it was reported to me.
 
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Brand Name14-IN MINIBORE SET W/MAXPLUS
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 Key11668137
MDR Text Key253193054
Report Number2243072-2021-01142
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
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 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMP9236-C
Device Lot Number20036437
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 Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2020
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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