MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Chest Pain (1776); Cyanosis (1798); Burning Sensation (2146); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 08/09/2020

Event Type  Injury  

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 after the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used, the patient reported feeling "strong heat and burning pain in the chest, jugular and facial extension".Guard medical alert was issued, and the patient then lost consciousness after a few seconds and went into respiratory arrest, with "cyanosis in the face and extremities".The patient was moved to the floor from the chair and a rescue chain was started "according to als", implementing a resuscitator and crash cart.After "20 seconds" of "cardiac massage and ventilation with ambu", the patient regained "ucid and oriented" consciousness.All vital parameters were restored, and blood controls were performed.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from italian to english: "nurse's report: during hohn-type cvc washing (17.25 hrs.Approx.), using 1 fl of pre-filled saline, the patient reports feeling of strong heat and burning pain in the chest, jugular and facial extension.About 10 ml of the same path is aspirated.Guard medical alert (mdg) is issued.After a few seconds the patient loses consciousness (concomitant arrival of the mdg) and is non-responsive to call/stimulus, in respiratory arrest - with cyanosis in the face and extremities.Absence of spontaneous breath and peripheral pulse.The patient is immediately placed on the floor (sitting in chair before the loss of consciousness).Started rescue chain according to als, called a resuscitator, there is a crash cart, initiating resuscitation maneuvers.After about 20 seconds of cardiac massage and ventilation with ambu, progressive recovery of consciousness, the patient is lucid and oriented, denies pain.Refers only sense of exhaustion.All vital parameters restored.Performed blood controls." "according to what we were told, unexpected reactions (mainly sensations of strong heat) after the administration of posiflush 10ml xs had already occurred two or three other times, so the report was considered inevitable, because (the head nurse could not give us further details about the characteristics of the patients and the therapies administered to them), in their opinion, the only constant element in all cases that occurred was the presence of posiflush.The only additional detail with respect to the report (which even the head nurse recognized as too generic, in order to arrive at logical conclusions) was that the reported patient had received a diuretic before the wash, so at the base of the disease there could be an excessive drop in blood pressure.".

Event Description

It was reported that after the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used, the patient reported feeling "strong heat and burning pain in the chest, jugular and facial extension".Guard medical alert was issued, and the patient then lost consciousness after a few seconds and went into respiratory arrest, with "cyanosis in the face and extremities".The patient was moved to the floor from the chair and a rescue chain was started "according to als", implementing a resuscitator and crash cart.After "20 seconds" of "cardiac massage and ventilation with ambu", the patient regained "ucid and oriented" consciousness.All vital parameters were restored, and blood controls were performed.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from italian to english: "nurse's report: during hohn-type cvc washing (17.25 hrs.Approx.), using 1 fl of pre-filled saline, the patient reports feeling of strong heat and burning pain in the chest, jugular and facial extension.About 10 ml of the same path is aspirated.Guard medical alert (mdg) is issued.After a few seconds the patient loses consciousness (concomitant arrival of the mdg) and is non-responsive to call/stimulus, in respiratory arrest - with cyanosis in the face and extremities.Absence of spontaneous breath and peripheral pulse.The patient is immediately placed on the floor (sitting in chair before the loss of consciousness).Started rescue chain according to als, called a resuscitator, there is a crash cart, initiating resuscitation maneuvers.After about 20 seconds of cardiac massage and ventilation with ambu, progressive recovery of consciousness, the patient is lucid and oriented, denies pain.Refers only sense of exhaustion.All vital parameters restored.Performed blood controls." "according to what we were told, unexpected reactions (mainly sensations of strong heat) after the administration of posiflush 10ml xs had already occurred two or three other times, so the report was considered inevitable, because (the head nurse could not give us further details about the characteristics of the patients and the therapies administered to them), in their opinion, the only constant element in all cases that occurred was the presence of posiflush.The only additional detail with respect to the report (which even the head nurse recognized as too generic, in order to arrive at logical conclusions) was that the reported patient had received a diuretic before the wash, so at the base of the disease there could be an excessive drop in blood pressure.".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 0154145 and the review did not reveal any detected quality issues during the production process that could have contributed directly to this reported incident.To aid in the investigation of this issue, twenty retained samples were returned for evaluation by our quality engineer team.All of the inspection tests, including bioburden tests, for this lot number were reviewed and the lot was found to be within specification prior to release.Based on the information provided, it is unlikely that saline in the bd posiflush product was a contributory factor to the reported incident.See h.10.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10511528
• MDR Text Key: 206287457
• Report Number: 9616657-2020-00138
• Device Sequence Number: 1
• Product Code: NGT
• 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,Followup
• Report Date: 09/22/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0154145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention