MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD PHASEAL¿ PROTECTOR P55; INTRAVASCULAR ADMINISTRATION SET

Model Number	515117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
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 while using bd phaseal¿ protector p55 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about chemo leakage with the use of protector.According to the customer's report, after attaching the protector to the vial of endoxan, leakage was observed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-mar-2023.H6: investigation summary: one sample received by our quality team for investigation.Upon visual evaluation, no defects or issues observed.Functional testing was performed, liquid inside the syringe could move to the vial and back to the syringe without issue and no leaks were observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.Further testing was conducted and after properly reconnecting the vial and protector, no sign of leakage occurred.A device history review was performed for reported lot 2201141 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no defects or issues observed.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.Based on the investigation results, it was determined that the protector was not properly connected to the vial which resulted in the leak reported.The protector must be attached completely vertical to the vial.
Event or Problem Description
It was reported while using bd phaseal¿ protector p55 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about chemo leakage with the use of protector.According to the customer's report, after attaching the protector to the vial of endoxan, leakage was observed.

• Brand Name: BD PHASEAL¿ PROTECTOR P55
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16607633
• Report Number: 9616066-2023-00544
• Device Sequence Number: 4756520
• Product Code: ONB
• UDI-Device Identifier: 30382905151171
• UDI-Public: (01)30382905151171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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 Model Number: 515117
• Device Catalogue Number: 515117
• Device Lot Number: 2201141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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