MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Insufficient Information (3190)

Patient Problem Tachycardia (2095)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that there was a reaction (allergic/etc.) with the bd posiflush sp.The following information was provided by the initial reporter: "post operative 17month old several hours after theatre.Nursing staff went to flush with the posiflush befre antibiotics.Child went floppy and grey and heart rate increased, breathing difficulties and medical emergency team was called.There was no other drugs given at the time only posiflush lot 3256857.At the time it was decided to quarantine all of that batch across the hospital to work out if there is something wrong with the batch before they release it.Query is whether allergic reaction to posiflush or there was something in the line as it had been several hours or something completely unrelated.".

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD POSIFLUSH SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19013854
• MDR Text Key: 339043914
• Report Number: 3002682307-2024-00068
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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 Catalogue Number: 306575
• Device Lot Number: 3256857
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other