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

Catalog Number	515304
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: 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 a crack in the bd phaseal¿ y-site connector c80 flushing site caused leakage.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
One picture sample for product number 515304 and lot number 524478 was received for evaluation by our quality engineer team.Through a review of the production history, no quality issues were found during the manufacture of lot number 524478 that could have contributed to the reported defect.Within the bd manufacturing site, the sealing of the membrane to the connector was performed on this product.The assembly and packaging of the product was performed at a subcontract location.In response to the reported incident, a complaint was opened with the subcontractor.The subcontractor was unable to identify an exact cause for this incident.Assembly and packaging roles are in the process of being transferred from the subcontract location to the bd manufacturing facility.This product is not assembled or packaged in bd san agustin plant.The process performed on our plant is the sealing of the membrane on the connector.Then, this piece is sent to a subcontractor (carefusion-it) where the set assembly and packaging is carried out according to buy specification sb1746.After the set assembly and packaging at carefusion-it- (now bd), some samples are sent to san agustin plant.Visual inspection is performed to verify the quality of the product according to fr-177 current version.
Event or Problem Description
It was reported that a crack in the bd phaseal y-site connector c80 flushing site caused leakage.There was no report of injury or medical intervention.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR C80
• 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: 7957493
• Report Number: 3003152976-2018-00427
• Device Sequence Number: 19275871
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 515304
• Device Lot Number: 524478
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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