MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O); INTRAVASCULAR ADMINISTRATION SET

Model Number 515056

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2021

Event Type  malfunction  

Event Description

It was reported that the tacro line disconnected from the bd phaseal¿ optima injector (n40-o) and leaked blood from the cvc lumen.The following information was provided by the initial reporter: "patient called nurse into room around 2100.Patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters casette.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: no samples are available for the investigation of the event reported.Based on picture received; no damages or issues can be observed on n40-o product that could lead to the event reported.A device history review was performed for reported lot 2105303, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Ten retained samples from the same lot were evaluated no issues were observed on the luer cone nor the luer thread.No damages can be observed on retained samples requested.Leakage test performed, no defects were observed.Functional testing was performed, sample was attached to a syringe+ a protector connected to a vial.After aspirating the colorant from the vial to the syringe, no issues or leakage were found on the injector.No luer lock disconnection occurred.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Testing results were reviewed for the reported lot and found all product met required specifications.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h.10.

Event Description

It was reported that the tacro line disconnected from the bd phaseal¿ optima injector (n40-o) and leaked blood from the cvc lumen.The following information was provided by the initial reporter: "patient called nurse into room around 2100.Patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters casette.".

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N40-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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12821645
• MDR Text Key: 284898043
• Report Number: 3003152976-2021-00761
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• UDI-Public: 00382905150562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201099
• 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: 12/29/2021

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 Expiration Date: 10/31/2023
• Device Model Number: 515056
• Device Catalogue Number: 515056
• Device Lot Number: 2105303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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