MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET

Model Number	515306
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 leaked when used with the liposomal doxorubicin bag.The following information was provided by the initial reporter: "pharmacist.Reported 1 liposomal doxorubicin bag had a leak in the oncology day unit when they opened the bag.The leak is originating from the ancillary item provided with the product; phaseal adaptor.Further information requested from customer.Including whether any leak was observed prior to removing product from overpouch, at which stage exactly the leak was identified, whether there was any skin contact with any spilled cytotoxic solution and if skin contact occurred, what actions were taken immediately after any spill skin contact, whether there was any report of staff / patient injury, or medical intervention as a result of this event, and whether there was any damage observed to the phaseal adaptor, the product packaging, or the carton the product was received in.This was identified at the hospital on (b)(6) 2023.".
Additional Manufacturer Narrative
H6: investigation summar.Photo received by our quality team for investigation.Upon visual evaluation, infusion adapter leaking by the adapter port is observed.The infusion adapters have a septum inside the adapter port which provides a seal, that once spiked, cannot be un-spiked as a leakage can occur.A device history review was performed for reported lot 2203218, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Three retained samples from the same lot were evaluated.The product was visually inspected, there was no damage or defects identified on the infusion adapters or septum's of the adapter port.Product undergoes a series of testing and inspections during manufacturing to ensure the quality and functionality of the device, including leakage testing.All records were reviewed for the reported lot and results were found to be acceptable, product met required specifications.Leakage testing was also performed on the retained samples and no leakages occurred.Based on the available information we are not able to determine a root cause related to our manufacturing process at this time, it appears as though the adapter port may have previously been spiked, resulting in the leak observed.H3 other text : see h10.
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 leaked when used with the liposomal doxorubicin bag.The following information was provided by the initial reporter: "pharmacist.Reported 1 liposomal doxorubicin bag had a leak in the oncology day unit when they opened the bag.The leak is originating from the ancillary item provided with the product; phaseal adaptor.Further information requested from customer.Including whether any leak was observed prior to removing product from overpouch, at which stage exactly the leak was identified, whether there was any skin contact with any spilled cytotoxic solution and if skin contact occurred, what actions were taken immediately after any spill skin contact, whether there was any report of staff / patient injury, or medical intervention as a result of this event, and whether there was any damage observed to the phaseal adaptor, the product packaging, or the carton the product was received in.This was identified at the hospital on (b)(6) 2023.".

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100
• 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: 16714625
• Report Number: 3003152976-2023-00129
• Device Sequence Number: 12581452
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: 00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 515306
• Device Catalogue Number: 515306
• Device Lot Number: 2203218
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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