MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD; STOPCOCK

Catalog Number 394601

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 the bd connecta¿ multiflo¿ 3-way multiple infusion manifold leaked adriablastine from the connection to the bag when connecting the lipiodol.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from french: "incident occurred on (b)(6) 2023 during a chemoembolization procedure.The chemoembolization bag containing adriablastine was connected to a becton dickinson laboratory 3-way valve, reference 394601.Upon connecting the lipiodol (iodinated contrast material) to the 3-way valve, the adriablastine was projected into the air.The intern was sprayed in the neck (vesicant drug ++), and a technician was also sprayed.The patient was not affected by these.It is recurrent that this tap reference leaks, a tray is always placed under the tap to collect the spills, but this is the first time that the product used is projected in the air.The intern wiped and rinsed the area thoroughly for 15 minutes and contacted upco for further action.The product, contaminated with chemo was disposed of.Current status of the patient: no clinical consequence for the patient/ but the product is vesicant, risk for the patient and the technicians of serious skin reactions.Actions taken in the health care institution for the management of the patient: change of tap by one of the same reference to start a new treatment".

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold leaked adriablastine from the connection to the bag when connecting the lipiodol.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from french: "incident occurred on (b)(6) 2023 during a chemoembolization procedure.The chemoembolization bag containing adriablastine was connected to a becton dickinson laboratory 3-way valve, reference (b)(4).Upon connecting the lipiodol (iodinated contrast material) to the 3-way valve, the adriablastine was projected into the air.The intern was sprayed in the neck (vesicant drug ++), and a technician was also sprayed.The patient was not affected by these.It is recurrent that this tap reference leaks, a tray is always placed under the tap to collect the spills, but this is the first time that the product used is projected in the air.The intern wiped and rinsed the area thoroughly for 15 minutes and contacted upco for further action.The product, contaminated with chemo was disposed of.Current status of the patient: no clinical consequence for the patient/ but the product is vesicant, risk for the patient and the technicians of serious skin reactions.Actions taken in the health care institution for the management of the patient: change of tap by one of the same reference to start a new treatment.".

• Brand Name: BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16900218
• MDR Text Key: 314900200
• Report Number: 9610847-2023-00105
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• 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