MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INJECTOR (N35-O); INTRAVASCULAR CATHETER

Catalog Number 515052

Device Problems Leak/Splash (1354); Incomplete or Inadequate Connection (4037)

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

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported bd phaseal optima injector (n35-o) had a leakage issue.The following information was provided by the initial reporter: "the nurse looked and saw that the female connector that should have been attached to the line with the taxol infusion wasn't attached and the medication was dripping onto the patient instead of infusing into her port.".

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported bd phaseal optima injector (n35-o) had a leakage issue.The following information was provided by the initial reporter: "the nurse looked and saw that the female connector that should have been attached to the line with the taxol infusion wasn't attached and the medication was dripping onto the patient instead of infusing into her port.".

Manufacturer Narrative

H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process, including testing to verify all critical dimensions are within specification such as the luer threading.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.

Event Description

It was reported bd phaseal optima injector (n35-o) had a leakage issue.The following information was provided by the initial reporter: "the nurse looked and saw that the female connector that should have been attached to the line with the taxol infusion wasn't attached and the medication was dripping onto the patient instead of infusing into her port.".

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-O)
• Type of Device: INTRAVASCULAR CATHETER
• 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: 13563952
• MDR Text Key: 286001606
• Report Number: 3003152976-2022-00071
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• 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