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

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.".

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.".

Manufacturer Narrative

H.6.Investigation summary: no physical samples that display the reported condition were provided for investigation.One photo was received which shows the optima injector connected to an infusion set.There is no visible damage or defect that can be identified within the photo.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As a lot number was unavailable for this incident, a device history record review could not be completed.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: UNSPECIFIED BD PHASEAL¿ OPTIMA CONNECTOR
• Type of Device: INTRAVASCULAR 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 Key: 14121356
• MDR Text Key: 289510544
• Report Number: 2243072-2022-00463
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/12/2022
• 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