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

Model Number	515102
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd phaseal¿ protector had issues with leakage.The following information was provided by the initial reporter: "a strong antibiotic spill occurred when a leak occurred between the bottle and a.Protector".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation: one sample was returned to our quality team for investigation.The product was visually inspected, no damage or defects were observed on the protector membrane, the needle of the protector penetrated the rubber stopper properly, although it was observed the needle penetrated the vial off center on the rubber stopper.Functional testing was performed, liquid inside the syringe could successfully move to the vial and back to the syringe without issue, however, a leakage between the protector and vial was observed.A device history review was performed for suspected lot 2103110 no deviations or non-conformances was identified during the manufacturing process that could have contributed to this issue.Product undergoes visual and functional evaluations throughout manufacturing, including leakage testing to ensure the quality of the membrane, and verification all critical dimensions are within specification.Based on the investigation and sample evaluation, it was determined this incident was likely due to an improper connection of the protector onto the vial.
Event or Problem Description
It was reported bd phaseal¿ protector had issues with leakage.The following information was provided by the initial reporter: "a strong antibiotic spill occurred when a leak occurred between the bottle and a.Protector".

• Brand Name: BD PHASEAL¿ 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13003619
• Report Number: 3003152976-2021-00813
• Device Sequence Number: 4646988
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123213
• 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): 01/25/2022

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: 02/28/2026
• Device Model Number: 515102
• Device Catalogue Number: 515102
• Device Lot Number: 2103110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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