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

Catalog Number	515202
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd phaseal¿connector there was an issue with leakage.It was stated ¿upon completion of chemo infusion, flush bag attached at clave site on tubing above pump cassette and infused.A second chemo was attached to the infusion tubing below the pump cassette on the clave connector closest to the patient - tubing was clamped.When the injector was removed from the connector (of the completed chemo), a few dots of fluid were noted on the pad under the connector these dots were probably saline from the flush".There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: since no physical or picture samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Since a lot number was unavailable for this incident, a production history review could not be performed and retained samples from the manufacturing facility could not be evaluated.During the molding process, visual inspections are performed for the connectors and quality dimensions are measured.During the assembly process, the welding and the position of the membrane and checked for accuracy.Leakage testing is also performed during the assembly process to ensure quality and functionality.Based on the limited investigation, a cause for the reported issue could not be determined.Based on the low severity and frequency of the defect, it was determined that no capa is required.

• Brand Name: BD PHASEAL¿CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7538242
• Report Number: 3003152976-2018-00225
• Device Sequence Number: 11121088
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 515202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other