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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after attaching bd phaseal¿ l connector c90 to saline bag fluid leakage occurred.This occurred on 6 occasions.There was no report of patient impact.The following information was provided by the initial reporter:we find that these l-connectors will not attach tightly to bags of 0.9% saline (vetivex) whereas they previously attached very well.When pushed into the saline bag fluid will leak around the edges, causing potential escape of cytotoxic agents (if the bag were to contain any).This has happened with all the c-90s we have used in this batch (at least 6).We have had to discard all c-90s used (and a number of fluid bags since.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 after attaching bd phaseal¿ l connector c90 to saline bag fluid leakage occurred.This occurred on 6 occasions.There was no report of patient impact.The following information was provided by the initial reporter:we find that these l-connectors will not attach tightly to bags of 0.9% saline (vetivex) whereas they previously attached very well.When pushed into the saline bag fluid will leak around the edges, causing potential escape of cytotoxic agents (if the bag were to contain any).This has happened with all the c-90s we have used in this batch (at least 6).We have had to discard all c-90s used (and a number of fluid bags since.
Additional Manufacturer Narrative
H.6.Investigation: no samples or photos received for investigation.A device history review was performed for the reported lot 2004103, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples from the same lot are evaluated, finding no defect in the tip.Throughout manufacturing, various inspections and tests are performed to avoid defective parts.During the molding process, the operator performs visual inspections of the connector and membrane.Quality-critical dimensions are measured for all connector housings.It is a manual assembly process, 100% of the parts are visually inspected.The correct welding and location of the membrane, parts without dirt and tip without damage is verified.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that after attaching bd phaseal¿ l connector c90 to saline bag fluid leakage occurred.This occurred on 6 occasions.There was no report of patient impact.The following information was provided by the initial reporter: we find that these l-connectors will not attach tightly to bags of 0.9% saline (vetivex) whereas they previously attached very well.When pushed into the saline bag fluid will leak around the edges, causing potential escape of cytotoxic agents (if the bag were to contain any).This has happened with all the c-90s we have used in this batch (at least 6).We have had to discard all c-90s used (and a number of fluid bags since.

• Brand Name: BD PHASEAL¿ L CONNECTOR C90
• Common Device Name: CLOSED ANTINEOPLASTIC & HAZARDOUS DRUG & TRANSFER SYS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12801116
• Report Number: 3003152976-2021-00749
• Device Sequence Number: 5547790
• Product Code: ONB
• UDI-Device Identifier: 00382905153051
• UDI-Public: 00382905153051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/13/2021

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: 03/31/2024
• Device Model Number: 515305
• Device Catalogue Number: 515305
• Device Lot Number: 2004103
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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