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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PHASEAL¿ OPTIMA CONNECTOR INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD PHASEAL¿ OPTIMA CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
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 (b)(4) has been listed and the (b)(4) 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 the unspecified bd phaseal¿ optima connector separated from the luer mating component during use. The following information was provided by the initial reporter: "patient returned to 3rd floor waiting area and informed desk that the 5fu line had come undone from injector/connector apparatus. This rn went to assess patient in lobby and then bring patient back to room on atc floor. Rn stopped cadd pump and then assessed port access, line, dressing, flushed line and had positive blood return and flushing with ease. Reconnected tubing to new injector and connector and blue safety cap. Resumed infusion via cadd pump and infusion running correctly. No other issues reported and patient stable upon discharging. ".
 
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Brand NameUNSPECIFIED BD PHASEAL¿ OPTIMA CONNECTOR
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14121356
MDR Text Key289510544
Report Number2243072-2022-00463
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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