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

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.

• Brand Name: BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)
• Type of Device: INTRAVASCULAR 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 Key: 14120860
• MDR Text Key: 289760715
• Report Number: 3003152976-2022-00139
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• 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 Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• 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 Sequence Number: 1
• Treatment: UNSPECIFIED BD TUBING