MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA PROTECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	515065
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phaseal¿ optima protector had the expansion chamber burst causing leakage.The following information was provided by the initial reporter: "  it was reported by the consumer the bubble popped in the phaseal causing leakage.".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phaseal¿ optima protector had the expansion chamber burst causing leakage.The following information was provided by the initial reporter: "  it was reported by the consumer the bubble popped in the phaseal causing leakage.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2109402, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Five retained samples of lot 2109402 were used for additional evaluation.The product was visually inspected, no damage or other defects were observed.Functional testing was performed, connecting the protector sample to both a vial, injector, and syringe per the instructions for use provided with the product.In all cases the expansion chamber expanded properly, liquid was able to be drawn from the vial, the expansion film did not burst, no leakage into the expansion chamber was observed, and the product functioned as intended.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device, all records were reviewed for the reported lot and results were found to be acceptable.Based on the available information we are not able to determine a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that bd phaseal¿ optima protector had the expansion chamber burst causing leakage.The following information was provided by the initial reporter: "  it was reported by the consumer the bubble popped in the phaseal causing leakage.".

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR
• 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: 13416867
• Report Number: 3003152976-2022-00036
• Device Sequence Number: 4690697
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: 00382905150654
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• 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): 03/03/2022

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: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 515065
• Device Catalogue Number: 515065
• Device Lot Number: 2109402
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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