MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P14; INTRAVASCULAR ADMINISTRATION SET

Model Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Patient¿s birthday was not provided, (b)(6) 1986 was used based on age of patient.H.3.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 p14 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking vial adaptors (p14) on the smaller drug vials.We have had a vial leak on us today after reconstitution lot # 2205101 , bortezomib 3.5mg (marcan) , not a viscous drug , drug at room temperature , the entire vial had to be wasted , assembly fixture was used , also happening with other small vials like pembrolizumab.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 29-jul-2023.H6: investigation summary: four protector samples received by our quality team for investigation.Upon visual evaluation, no defects or issues observed.Further testing was conducted and after properly reconnecting the vial and protector, no sign of leakage occurred.A review of the device history was performed for lot 2205101, no deviations or non-conformances related to the reported problem were identified during the manufacturing process.Five retained samples from the same lot were used for further evaluation.The protectors were successfully connected to the vials, ensuring that they fitted correctly.The product was evaluated, and no damage or defects were observed.Functional tests were performed on the samples and no leakage was identified between the protector and the vial.The product undergoes visual and functional testing throughout manufacturing, including leak testing.Based on the investigation results, possible root cause is associated with protector not properly connected to the vial which resulted in the leak reported.The protector must be attached completely vertical to the vial during assembly.
Event or Problem Description
It was reported while using bd phaseal¿ protector p14 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking vial adaptors (p14) on the smaller drug vials.We have had a vial leak on us today after reconstitution: lot # 2205101, bortezomib 3.5mg (b)(6) , not a viscous drug, drug at room temperature, the entire vial had to be wasted, assembly fixture was used, also happening with other small vials like pembrolizumab.

• Brand Name: BD PHASEAL¿ PROTECTOR P14
• 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 ; 8448235433
• MDR Report Key: 16989954
• Report Number: 3003152976-2023-00194
• Device Sequence Number: 6296337
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/31/2023

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: 515100
• Device Catalogue Number: 515100
• Device Lot Number: 2205101
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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 Age: 37 YR
• Patient Sex: Female