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

Catalog Number 515304

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894); Connection Problem (2900); Application Program Problem: Medication Error (3198)

Patient Problem Chemical Exposure (2570)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a home infusion of 5fu chemotherapy leaked from a bd phaseal¿ y-site connector c80 and a patient's hands were exposed to the medication.A nurse immediately discontinued the infusion and disposed of it properly.It was unknown how much of the medication the patient received and it was decided to not continue with treatment until the patient's next round at a later date.There was no report of medical intervention for this incident.Additionally, it was noted that when the pharmacy staff prepared the 5fu cadd pump for home infusion they made 2 connections to the y-port connector on the extension set with the phaseal injector in order to inject medication into the pump cartridge.They did not notice any leaking at the start of the infusion prior to the patient being discharged to home.There was no phaseal injector or connector at the distal end of the cadd pump set.Nursing made a traditional connector of the cadd pump tubing to the patient huber needle port set.

Manufacturer Narrative

A sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR C80
• Type of Device: CHEMOTHERAPY ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6564819
• MDR Text Key: 75310284
• Report Number: 3003152976-2016-00018
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 515304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other