MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P55); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage occurred between the bd phaseal¿ protector (p55) and vial while preparing endoxan.This occurred with 2 protectors.The following information was provided by the initial reporter, translated from japanese: "this report is about leakage from the protector (p55).During preparation of endoxan for injection, leakage was observed from the vial after the protector was attached.The event was identified by water droplets on the sheet.Possible batch number: 2302125 or 2301131".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Lot number was not reported; however, a potential lot number was provided.The information for that number is as follows: d.4.Medical device lot #: 2302125.D.4.Medical device expiration date: 31-jan-2028.H.4.Device manufacture date: 17-feb-2023.D.4.Medical device lot #: 2301131.D.4.Medical device expiration date: 31-dec-2027.H.4.Device manufacture date: 30-jan-2023.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-aug-2023.H6: investigation summary two samples were provided to our quality team for investigation.The product was evaluated and a leakage between the vial and protector was observed in one of the samples, no leak was identified in the second sample.Upon inspecting the product it was noted that the puncture within the stoppers of the vial was significantly larger than the spike of the protector.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.A device history review was performed for suspected lots 2302125 and 2301131, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of each lot were used for additional evaluation.The protectors were successfully connected to the vials, ensuring they fit properly.The product was evaluated and no damage or defects were observed.Functional testing was performed on the samples, no leak between the protector and vial was identified.Based on our quality team's investigation, we cannot identify a root cause related to our manufacturing process at this time.It is likely the leak was related to the quality of the stopper as well as the assembly of the protector onto the vial.The protector must be attached completely vertical.
Event or Problem Description
It was reported that leakage occurred between the bd phaseal¿ protector (p55) and vial while preparing endoxan.This occurred with 2 protectors.The following information was provided by the initial reporter, translated from japanese: "this report is about leakage from the protector (p55).During preparation of endoxan for injection, leakage was observed from the vial after the protector was attached.The event was identified by water droplets on the sheet.Possible batch number:2302125 or 2301131".

• Brand Name: BD PHASEAL¿ PROTECTOR (P55)
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17560538
• Report Number: 3003152976-2023-00338
• Device Sequence Number: 17053840
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: 00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• 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): 10/17/2023

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 Catalogue Number: 515117
• Device Lot Number: SEE H10
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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