MAUDE Adverse Event Report: BD 0.9% SODIUM CHLORIDE INJECTION 10ML, POSIFLUSH; FLUSH SYRINGE

Catalog Number 8290-306546

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Hypoxia (1918); Rash (2033); Shock (2072); Anaphylactoid (2218); Reaction (2414)

Event Date 08/22/2015

Event Type  Injury  

Event Description

Pt had a picc lone placed without complication.Following flush using a bd posiflush ns syringe, the pt developed refractory shock, hypoxemia, and chest pain.Pt was transferred to icu and treated with iv fluid resuscitation and norepinephrine.Pt also developed a diffuse rash.Over the next 3 hours, pt's symptoms improved, was weaned off vasopressors and oxygen.The icu team in consult with infectious disease reviewed the possible causes and were "left to conclude that he had anaphylactic or anaphylactoid reaction related to saline flush that was injected into picc line".Id provider suspected possible endotoxin contamination given the reaction and presentation ('immediate proximity to first flush.Shower of endotoxemia").No other reactions reported in this facility with ns flushes.Currently working to explore lab testing to analyte for presence of endotoxin, or other contaminant within the ns flush.Three different lot number available at time of flush (not documented which lot number was used on pt).Possible impact flush lots include 5119767 (exp: 04/2018; 50979952 (exp: 02/2018); 5079661 (exp: 03/2018).Other possible cause is allergy to chlorhexidine topical wipe (ige lab pending).Diagnosis or reason for use: flush new central line placement.Event abated after use stopped or dose reduced: yes.

• Brand Name: 0.9% SODIUM CHLORIDE INJECTION 10ML, POSIFLUSH
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD
• MDR Report Key: 5045399
• MDR Text Key: 24873728
• Report Number: MW5055855
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Report Date: 08/26/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 8290-306546
• Device Lot Number: 5079952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Weight: 160