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

Catalog Number 515070

Device Problem Separation Problem (4043)

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

Event Date 10/12/2021

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 when using the bd phaseal¿ optima connector (c35-o), the device experienced separation of the injector and its mating component. The following information was provided by the initial reporter. The customer stated: patient arrived to ctrc r1 with tk216 iv continuous home infusion via cadd pump tubing disconnected. Patient reports it got disconnected earlier and pt tried to reconnect but tubing keeps getting disconnected. Patient also reports that he lost optima infusion clamp while sleeping and could not find it. No spill noted/ reported. Per patient, pump was stopped around an hour before ctrc arrival. Phaseal optima connector replaced by ctrc rn; optima infusion clamp placed. Infusion re-started, teaching reinforced on trouble shooting and reported event to research team.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12821012
• MDR Text Key: 285473604
• Report Number: 3003152976-2021-00760
• 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,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 515070
• Device Lot Number: 2106504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/16/2021 Patient Sequence Number: 1

Treatment

INJECTOR LOCKING N40-O