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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515070
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Event Description
It was reported that the bd phaseal¿ optima connector (c35-o) separated from the luer mating component during use. The following information was provided by the initial reporter: "patient came to atc floor and reported that the tubing had become disconnected from injector/connector site. Brought patient back to atc floor. Assessed port line. Port flushing with ease and blood return noted accordingly. Patient not in distress and not complaining of any pain at site. Assessed pump and infusion set. Tubing came separated at site where connector is placed. Confirmed with nurse that connections were checked and tightened on wednesday when pump was initially connected. Blue safety clamp in place. Replaced all items, injector, connector and blue safety clamp. Infusion pump running accordingly. Patient will return at disconnect time later today. ".
 
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or physical samples that display the reported condition were available for investigation. Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device. As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated. Based on the available information we are not able to identify a root cause at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
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Brand NameBD PHASEAL¿ OPTIMA CONNECTOR (C35-O)
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14120860
MDR Text Key289760715
Report Number3003152976-2022-00139
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181221
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 04/07/2022
1 Device was Involved in the Event
1 Patient was 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 Number515070
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
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

Patient Treatment Data
Date Received: 04/15/2022 Patient Sequence Number: 1
Treatment
UNSPECIFIED BD TUBING
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