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	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd phaseal¿connector leaked.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.
Event or Problem Description
It was reported that the bd phaseal connector leaked.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that the bd phaseal¿connector leaked.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: as no picture samples or actual samples were available for return, a thorough sample investigation could not be completed.Since a lot number was unavailable for this incident, a production history review could not be performed and retained samples could not be evaluated.During the manufacturing process of the connector product, inspections are regularly performed.During the molding process, visual inspections are performed, critical quality dimensions are measured, and tip luer diameter is verified.During the assembly process, the welding and position of the membrane is verified as well as the absence of foreign matter.Finally, leakage testing is performed to ensure the quality and functionality of the membrane according to procedure.Based on the limited investigation, a definite cause for the alleged incident could not be determined.

• 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: 7736230
• Report Number: 3003152976-2018-00353
• Device Sequence Number: 19525768
• Product Code: FPA
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018; 07/10/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/21/2018; 09/27/2018
• 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