MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515312

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

It was reported that the bd phaseal¿ secondary set (c62) leaked cytostatic medicine from the tube connection.The following information was provided by the initial reporter: in the pharmacy they prepared cystostatics with phaseal and c62 (several years already).Now they realized leakage from the connecting point of connector and the tube.This product is destroyed as it's cystostatic contaminated.

Manufacturer Narrative

(b)(4).Investigation summary: one photo was provided to our quality team for investigation.The final product for lot ta12092 is assembled and packaged at a supplier site.We notified the supplier of the reported issue and provided the photo for evaluation.Upon visually inspecting the photo that was received, a drop of liquid is observed outside the set, near the y-site.There is no evidence of damage or a break at this connection.Retained samples were used for additional evaluation, there were no visual defects noted and all product was manufactured according to specification.It was thought that excessive force by the operator when connecting the connector piece to the y-site could have been a potential cause for this incident.All testing was reviewed for the reported lot, including leakage, torque, and inspection results with no issues identified related to the reported malfunction.Without the physical sample we cannot verify any damage to the product or determine where the liquid originated therefore we were not able to identify a definitive root cause related to the manufacturing process at this time.Complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL SECONDARY SET (C62)
• 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: 11382437
• MDR Text Key: 280447911
• Report Number: 3003152976-2021-00110
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 515312
• Device Lot Number: TA12092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1