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	01/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).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¿ y-site connector c80 leaked product onto the health care worker¿s face at the end of the cytarabine.There was no report of injury or medical intervention noted.
Event or Problem Description
It was reported that the bd phaseal¿ y-site connector c80 leaked product onto the health care worker¿s face at the end of the cytarabine.There was no report of injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: as no physical or picture samples were received and a lot number was unavailable, neither a sample evaluation nor a production history review could be completed.For product 515304, bd performs the sealing of the membrane on the connector.This product is assembled and packaged within a subcontract location.Bd sent the subcontractor the information from this incident for review.Based on the limited investigation results, a cause for the alleged defect could not be identified.Investigation conclusion: one complaint was sent to the subcontractor (including all issues described on complaints (b)(4) which come from the same hospital.The lot number is unknown.Dhr cannot be reviewed and retained samples cannot be checked.The root cause cannot be established.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, 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 manufacturer: no.This supplemental mdr also corrects the following fields: b.5.It was reported that the "tip to put the rinsing was cracked" on the bd phaseal¿ y-site connector c80.A the end of he cytarbine, the user pushed 2cc as a rinse, and received "a few drops of product" on the face.No medical intervention was noted.Type of reportable events: serious injury.
Event or Problem Description
It was reported that the "tip to put the rinsing was cracked" on the bd phaseal¿ y-site connector c80.A the end of he cytarbine, the user pushed 2cc as a rinse, and received "a few drops of product" on the face.No medical intervention was noted.

• 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: 7684067
• Report Number: 3003152976-2018-00286
• Device Sequence Number: 1315840
• 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,Followup
• Report Date (Section B): 08/15/2018

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: 515304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 06/20/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/02/2018; 09/19/2018
• 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