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

Catalog Number 515052

Device Problem Leak/Splash (1354)

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

Event Date 11/16/2021

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 that the bd phaseal optima injector (n35-o) experienced leakage from the injector and mating component.The following information was provided by the initial reporter: leaking, either between the needle and connector or the connector and injector.

Manufacturer Narrative

H6: investigation summary: photos received for investigation.Upon visual inspection, an injector, connector, and needle is displayed.Unable to observe leakage on images received.A device history review was performed for reported lot 2102318, 2012504, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including leakage and that all critical dimensions are within specification and there is no damage on the product.Five retained samples from the same lot are evaluated.Upon visual inspection of the samples requested, no defects can be observed.Further testing was conducted, no sign of leakage occurred.Functional testing was performed, penetrating the injector along with a sample syringe and mating components ten times, all results were found to be acceptable with no leaks identified.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

Event Description

It was reported that the bd phaseal optima injector (n35-o) experienced leakage from the injector and mating component.The following information was provided by the initial reporter: leaking, either between the needle and connector or the connector and injector.

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-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: 13113323
• MDR Text Key: 284862194
• Report Number: 3003152976-2021-00868
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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: 04/30/2022
• Device Catalogue Number: 515052
• Device Lot Number: 2102318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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
• Treatment: MATL# 515070 LOT# 2012504 CONNECTOR C35-O