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

Model Number	515057
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported bd phaseal optima injector (n40-o multi) had leakage issues.The following information was provided by the initial reporter: "nurse noticed drug on the floor and dripping from the tubing (alaris #11426964) towards the end of the infusion.Chemo was administered at approx 500 ml/ hr with an alaris pump.Customer felt that the leak occurred between the spin collar connection and the phaseal optima injector (product 515057), which had been attached in pharmacy.".
Event or Problem Description
It was reported bd phaseal optima injector (n40-o multi) had leakage issues.The following information was provided by the initial reporter: "nurse noticed drug on the floor and dripping from the tubing (alaris #11426964) towards the end of the infusion.Chemo was administered at approx 500 ml/ hr with an alaris pump.Customer felt that the leak occurred between the spin collar connection and the phaseal optima injector (product 515057), which had been attached in pharmacy.".
Additional Manufacturer Narrative
H6: investigation summary: one photo received for investigation, showing one optima injector n40-0 connected to an iv tubing.A leak is noticed in the iv tubing, before the section that connect the luer lock part from the iv tubing and the luer thread from optima injector n40-o.No leak can be noticed between the luer thread from the optima injector n40-o and the luer part from the iv tubing.Since no physical sample was received, root cause of the event reported could not be confirmed.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see h10.

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N40-O MULTI)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12367965
• Report Number: 3003152976-2021-00504
• Device Sequence Number: 4116151
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: 00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Other
• Device Model Number: 515057
• Device Catalogue Number: 515057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1