MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI); INTRAVASCULAR ADMINISTRATION SET

Model Number	515079
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ optima infusion adapter (c100-0 multi) membrane was missing when spiking it into the bag, causing chemotherapy medicine to leak from the tubing port.The following information was provided by the initial reporter: "when checking dose, drug was dripping from phaseal adapter site.5-10 drops was caught by chemo mat.Dose was discarded.New dose was prepared for patient.Phaseal lot number 2103501.Area was cleaned.Spill documented." "the product involved is the c-100-o infusion adapter that is spiked into the bag prior to dispensing.The leak came from the port where the tubing is attached which has a membrane prior to spiking.This one appears to be defective in that it was missing and therefore chemo spilled out.".
Additional Manufacturer Narrative
H6: investigation: no samples or photos received for investigation.A device history review was performed for lot 2103501, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Fourteen retained samples from the same lot were evaluated no issues or damaged observed.Thickness from the ia port septum from all retained samples were measured by metrology team and dimensions meet specifications.
Event or Problem Description
It was reported that the bd phaseal¿ optima infusion adapter (c100-0 multi) membrane was missing when spiking it into the bag, causing chemotherapy medicine to leak from the tubing port.The following information was provided by the initial reporter: "when checking dose, drug was dripping from phaseal adapter site.5-10 drops was caught by chemo mat.Dose was discarded.New dose was prepared for patient.Phaseal lot number 2103501.Area was cleaned.Spill documented." "the product involved is the c-100-o infusion adapter that is spiked into the bag prior to dispensing.The leak came from the port where the tubing is attached which has a membrane prior to spiking.This one appears to be defective in that it was missing and therefore chemo spilled out.".

• Brand Name: BD PHASEAL¿ OPTIMA INFUSION ADAPTER (C100-0 MULTI)
• Common Device Name: 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: 12556878
• Report Number: 3003152976-2021-00647
• Device Sequence Number: 1101521
• Product Code: ONB
• UDI-Device Identifier: 00382905150791
• UDI-Public: 00382905150791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• 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): 10/27/2021

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 Expiration Date: 05/31/2022
• Device Model Number: 515079
• Device Catalogue Number: 515079
• Device Lot Number: 2103501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown