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	05/13/2021
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) fell out of the packaging and onto the floor while hanging it on the pole.The following information was provided by the initial reporter: "phaseal optima infusion adaptor fell out of the bag and onto the floor as nurse was going to hang it on pole.".
Additional Manufacturer Narrative
Investigation summary: no photos or physicals samples that display the reported issue were provided for investigation.A device history review was performed for reported lot 2012701, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected, there was no damage or other defects observed on the infusion adapter.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.All retained samples underwent these evaluations and product was verified to meet required limits, including proper spike length and diameter.Based on the available information, we cannot identify a root cause related to our manufacturing process at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that the bd phaseal¿ optima infusion adapter (c100-0 multi) fell out of the packaging and onto the floor while hanging it on the pole.The following information was provided by the initial reporter: "phaseal optima infusion adaptor fell out of the bag and onto the floor as nurse was going to hang it on pole.".

• 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
• MDR Report Key: 11969339
• Report Number: 3003152976-2021-00322
• Device Sequence Number: 4366845
• Product Code: ONB
• UDI-Device Identifier: 00382905150791
• UDI-Public: 00382905150791
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/30/2021

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: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 515079
• Device Catalogue Number: 515079
• Device Lot Number: 2012701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1