MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL ¿ L CONNECTOR C90J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515309

Device Problems Leak/Splash (1354); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple potential lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2111212, medical device expiration date: 31oct2025, device manufacture date: 19nov2021; medical device lot #: 2111214, medical device expiration date: 31oct2025, device manufacture date: 23nov2021.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd phaseal ¿ l connector c90j the membrane separated and 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 separation of the membrane of l-connector, resulting in chemo leakage.When the hcp disengaged the injector from the l-connector, the membrane was separated from the l-connector, resulting in leakage of the anticancer agent.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 11sep2022.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, therefore the system was open and leaked when used.A device history review was performed for suspected lots 2111212, 2111214, and 2201207, 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 project was initiated to further address this issue and prevent any reoccurrence.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

Event Description

It was reported while using bd phaseal ¿ l connector c90j the membrane separated and 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 separation of the membrane of l-connector, resulting in chemo leakage.When the hcp disengaged the injector from the l-connector, the membrane was separated from the l-connector, resulting in leakage of the anticancer agent.

• Brand Name: BD PHASEAL ¿ L CONNECTOR C90J
• Type of Device: 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 ; 8015296192
• MDR Report Key: 15407247
• MDR Text Key: 306088745
• Report Number: 3003152976-2022-00413
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 515309
• Device Lot Number: 2201207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1