MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Confusion/ Disorientation (2553)

Event Date 01/06/2023

Event Type  Injury  

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml an adverse event without an identified device problem occurred.There was no report of patient impact.The following information was provided by the initial reporter: today i got an odd taste in my upper airway and throat, similar to the feeling i get from a ct scan.It was like ether.Today at (b)(6) hospital in australia oncology day ward instead of saline they used a bd posiflush prefilled syringe.Within 30 minutes, i was confused,disorientated, memory loss, i did not know where i was.Went back to the ward and 8 people rushing around saying things like ¿stay with us lynn¿ i could feel myself drifting off.Male nurse who flushed the port said he had another patient with the same issues and ether like taste.He said i looked absolutely dreadful during this frightening event.

Manufacturer Narrative

Patient¿s birthday was not provided, (b)(6) 1952 was used based on age of patient.Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml an adverse event without an identified device problem occurred.There was no report of patient impact.The following information was provided by the initial reporter: today i got an odd taste in my upper airway and throat, similar to thefeeling i get from a ct scan.It was like ether.Today at (b)(6) hospital in australia oncology day wardinstead of saline they used a bd posiflush prefilled syringe.Withing 30 minutes, i was confused,disorientated, memory loss, i did not know where i was.Went back to the ward and 8 people rushing aroundsaying things like ¿stay with us lynn¿ i could feel myself drifting off.Male nurse who flushed the port said hehad another patient with the same issues and ether like taste.He said i looked absolutely dreadful during thisfrightening event.

Manufacturer Narrative

H6: investigation summary : a device history record review was completed for provided material number 306572 and lot number 2052102.The review found no possible non-conformances during the production process that could have contributed to this reported incident.All relevant in process and finished product inspections performed during this lot were found to be within specification.These test results ensure that the product was fit for its intended use and met the standard requirements for the product.As samples were unavailable for return, a thorough sample analysis could not be performed.As per product specifications, the composition/ingredients of the 0.9% saline posiflush xs product (material number 306572, lot number 2052102) is sodium chloride dissolved in water for injection, to produce a 0.9% sodium chloride solution.In addition, this product is not made with natural rubber latex or preservatives.This product is non-toxic and non-pyrogenic.Silicone is used as a lubricant in the syringe and is of a medical grade.H3 other text : see h10.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16238565
• MDR Text Key: 308066715
• Report Number: 9616657-2023-00002
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• 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: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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: 306572
• Device Lot Number: 2052102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR