MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60; CLOSED DRUG DELIVERY SYSTEM

Catalog Number	515301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.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 bd phaseal¿ secondary set drip chamber c60 are leaking where the bag is spiked.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: as neither a lot number nor a sample were available for this incident, a complete investigation consisting of a sample analysis and a production history review could not be performed.The connector component is manufactured within a bd facility.During the connector molding process and assembly process, regular inspections are performed to avoid faulty product.The secondary set is manufactured at a subcontractor location.After manufacturing is completed, final samples are sent to a bd facility for quality testing.A complaint has been sent to our subcontractor location regarding this incident.Based on the limited investigation, a definite cause for the reported incident could not be determined.
Event or Problem Description
It was reported that bd phaseal¿ secondary set drip chamber c60 are leaking where the bag is spiked.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60
• Common Device Name: CLOSED DRUG DELIVERY SYSTEM
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7828423
• Report Number: 3006948883-2018-00164
• Device Sequence Number: 1835402
• Product Code: ONB
• UDI-Device Identifier: 00382905153013
• UDI-Public: 382905153013
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 515301
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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