MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ L CONNECTOR C90; CLOSED ANTINEOPLASTIC & HAZARDOUS DRUG & TRANSFER SYS

Model Number	515305
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ l connector c90 experienced device damage while still considered operable.The following information was provided by the initial reporter: we had a problem with a phaseal connector (c90) where the valve was not working and the product leaked into the transport bag.This incident has not happened again for the moment.Per follow up received from customer: it seems that the internal valve has fallen at the connector and the product was flowing through the connector.I attach a picture of the device where we can see the absence of the valve.Closed transfer system connected to an ecoflac containing a chemotherapy product.The system has a leak and the product leaks into the transport bag.Clinical consequences and current status of the patient or person involved: no consequences on the patient.Leak identified by the nurse upon receipt of the product.Actions taken in the establishment: device kept in the pharmacy.
Additional Manufacturer Narrative
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¿ l connector c90 experienced device damage while still considered operable.The following information was provided by the initial reporter: we had a problem with a phaseal connector (c90) where the valve was not working and the product leaked into the transport bag.This incident has not happened again for the moment.Per follow up received from customer: it seems that the internal valve has fallen at the connector and the product was flowing through the connector.I attach a picture of the device where we can see the absence of the valve.Closed transfer system connected to an ecoflac containing a chemotherapy product.The system has a leak and the product leaks into the transport bag.Clinical consequences and current status of the patient or person involved: no consequences on the patient.Leak identified by the nurse upon receipt of the product.Actions taken in the establishment: device kept in the pharmacy.
Additional Manufacturer Narrative
Correction: imdrf annex a grid: a0413.
Additional Manufacturer Narrative
Correction: imdrf annex a grid: a0506.
Event or Problem Description
It was reported that the bd phaseal¿ l connector c90 experienced device damage while still considered operable.The following information was provided by the initial reporter: we had a problem with a phaseal connector (c90) where the valve was not working and the product leaked into the transport bag.This incident has not happened again for the moment.Per follow up received from customer: it seems that the internal valve has fallen at the connector and the product was flowing through the connector.I attach a picture of the device where we can see the absence of the valve.Closed transfer system connected to an ecoflac containing a chemotherapy product.The system has a leak and the product leaks into the transport bag.Clinical consequences and current status of the patient or person involved: no consequences on the patient.Leak identified by the nurse upon receipt of the product.Actions taken in the establishment: device kept in the pharmacy.
Event or Problem Description
It was reported that the bd phaseal¿ l connector c90 experienced device damage while still considered operable.The following information was provided by the initial reporter: we had a problem with a phaseal connector (c90) where the valve was not working and the product leaked into the transport bag.This incident has not happened again for the moment.Per follow up received from customer: it seems that the internal valve has fallen at the connector and the product was flowing through the connector.I attach a picture of the device where we can see the absence of the valve.Closed transfer system connected to an ecoflac containing a chemotherapy product.The system has a leak and the product leaks into the transport bag.Clinical consequences and current status of the patient or person involved: no consequences on the patient.Leak identified by the nurse upon receipt of the product.Actions taken in the establishment: device kept in the pharmacy.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 05-oct-2022.H6: investigation summary: one sample was provided to our quality team for investigation.After visual inspection, it was observed that the membrane was never assembled onto the connector body.A device history review was performed for lot 2201204, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples were used for additional evaluation.All product was visually inspected and verified the membranes were properly assembled.Assembly of the membrane is performed manually.A detection system is used to verify the proper welding and location of the membrane.All quality records verify the inspections were performed according to procedure.While we cannot identify a direct issue, it was determined this incident is due to the operator not properly welding the membrane onto the connector body and the detection system also not identifying/rejecting the impacted piece.A capa has been initiated to further address this issue and prevent any reoccurrence.

• Brand Name: BD PHASEAL¿ L CONNECTOR C90
• Common Device Name: CLOSED ANTINEOPLASTIC & HAZARDOUS DRUG & TRANSFER SYS
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15620448
• Report Number: 3002682307-2022-00275
• Device Sequence Number: 20389474
• Product Code: ONB
• UDI-Device Identifier: 00382905153051
• UDI-Public: 00382905153051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 12/27/2022

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: Other
• Device Expiration Date: 12/31/2025
• Device Model Number: 515305
• Device Catalogue Number: 515305
• Device Lot Number: 2201204
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 12/07/2022; 12/07/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/21/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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