MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ Y-SITE CONNECTOR C80; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515304

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

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 Description

It was reported that are leakage/disconnections between the bd phaseal¿ y-site connector c80, extension tubing, and cadd legacy plus 6500 devices.

Event Description

It was reported that are leakage/disconnections between the bd phaseal¿ y-site connector c80, extension tubing, and cadd legacy plus 6500 devices.

Manufacturer Narrative

Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.No device history records could be reviewed without a lot number.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR C80
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8133782
• MDR Text Key: 129614835
• Report Number: 3003152976-2018-00540
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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
• Device Operator: Other
• Device Catalogue Number: 515304
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other