MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI); INTRAVASCULAR ADMINISTRATION SET

Model Number	515057
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n40-o multi) experienced leakage.The following information was provided by the initial reporter: clinician knew there was a leak because when the medication is exposed to air it crystalizes.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n40-o multi) experienced leakage.The following information was provided by the initial reporter: clinician knew there was a leak because when the medication is exposed to air it crystalizes.
Additional Manufacturer Narrative
H.6.Investigation summary: two photos were provided to our quality team for investigation.While the drug crystallization reported could be observed, there was no damage or defects identified on the injector luer.A device history review was performed for reported lot 2108304, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Five retained samples of the same lot were used for additional evaluation.All product was visually inspected, no damage was observed.Functional testing was performed, filling a syringe with water and connecting it to the injector.In all cases the product functioned as intended and no leaks were identified.Dimensional testing was also completed, 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 our product or manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI)
• Common Device Name: 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: 14720072
• Report Number: 3003152976-2022-00268
• Device Sequence Number: 20035579
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: 00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 515057
• Device Catalogue Number: 515057
• Device Lot Number: 2108304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown