ORAL BAXTER SYRINGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for ORAL BAXTER SYRINGE manufactured by Baxter Healthcare Corporation.

Event Text Entries

[184159129] Rn attempted to connect oral baxter syringe of liquid morphine 5 mg into peripheral iv port. Second rn walked in to room and notified the rn involved that the syringe was not intended for iv but for oral administration. First rn stated that upon attempting to insert medication into iv, the med leaked onto patient? S arm; 0. 2 ml of a total 1 ml volume was missing from syringe. Iv line was removed immediately, md, charge nurse, pharmacy and oncology director notified. Morphine liquid spilled on patient? S arm. Further testing of nexiva catheter revealed that an iv connection may be possible with vigorous efforts. Existing medication safety project to implement enfit syringe conversion escalated through quality/patient safety. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5093736
MDR Report Key	9829265
Date Received	2020-03-12
Date Added to Maude	2020-03-13
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	UNKNOWN
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	ORAL BAXTER SYRINGE
Generic Name	DISPENSER, LIQUID MEDICATION
Product Code	KYX
Date Received	2020-03-12
Device Availability	*
Device Sequence No	1
Device Event Key	0
Manufacturer	BAXTER HEALTHCARE CORPORATION

Device Sequence Number: 101

Brand Name	MORPHINE LIQUID 5 MG
Product Code	---
Date Received	2020-03-12
Device Sequence No	101
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-12