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

Catalog Number 515070

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device manufacture date: unknown.(b)(4).Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no lot information or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd phaseal¿ optima connector (c35-o) separated from the microclave.This occurred 2 times during two different 24-hour infusions.The following information was provided by the initial reporter: "2.Fyi bmt has had two more disconnects connector has separated from the microclave on two 24 hour infusions.We are re-educating during annual skill sessions this summer about making sure the connection is tight and seated on all the threads.".

• Brand Name: BD PHASEAL OPTIMA 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10248437
• MDR Text Key: 212324734
• Report Number: 3003152976-2020-00295
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181221
• 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
• Report Date: 06/24/2020

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 Catalogue Number: 515070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other