MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515070

Device Problems Leak/Splash (1354); Separation Problem (4043)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported while using bd phaseal¿ optima infusion connector c35-o a the connector disconnected from the tubing and leaked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported leakage from tubing disconnect.

Event Description

It was reported while using bd phaseal¿ optima infusion connector c35-o a the connector disconnected from the tubing and leaked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported leakage from tubing disconnect.

Manufacturer Narrative

H6: investigation summary no physical samples that display the reported condition were provided for investigation.One photo of the injector was received.Through visual inspection, the connector is observed to be disconnected from the tubing.There is no visible damage to the connector.A device history review was performed for lot 2110512, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.One annotation was noted during the molding process for the connector body.It was identified that the cavity was not completely filled when forming the piece.The issue was solved in process, all product underwent inspections, and records verify proper process was followed to solve the issue and segregate impacted product.Given we do not have a physical sample to evaluate, we cannot confirm this is related to any issues with the luer.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Dimensional testing was performed, including the luer thread, verifying all critical dimensions are within specification.Product undergoes a series of visual and functional evaluations throughout the manufacturing process.Records were reviewed for the reported lot and no issues related to this failure were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• Brand Name: BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13716038
• MDR Text Key: 286995855
• Report Number: 3003152976-2022-00096
• Device Sequence Number: 1
• Product Code: ONB
• 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: 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: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 515070
• Device Lot Number: 2110512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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