MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE; SALINE FLUSH

Catalog Number 306572

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 that a patient had a reaction after using bd posiflush¿ xs pre-filled flush syringe.Verbatim: "we have received an adverse event report on 28 feb 2019 whereby patient concerned was reported to be experiencing nausea and vomiting episodes.Patient concerned attended local hospital - further information has since been obtained from fresnius nursing team to advise the event is not related to parenteral nutrition; but due to patients' underlying condition.Parenteral nutrition was not connected.Product: 306572 pfs p/flush xs saline, batch: 8270683, use: 10 ml to flush the line before and 20 ml after each infusion - as directed.Sample: no.Can you please provide your case reference for our records?".

Manufacturer Narrative

Investigation: a dhr was performed and the non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute to the complaint verbatim reported by the customer.With no sample returned there is no evidence that posiflush syringe was responsible for this reaction.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.Based on the information provided, it is more probable than not that the symptoms described may be an allergic reaction; however, it is highly improbable that this reaction was produced by the normal saline in the bd posiflush product.During the period 2017-2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction, apart from fresenius kabi uk.There are no known allergies to normal saline, either topical or within the body.It is most likely that whatever fluid was in the iv line prior to flushing contained inadequately flushed medication or glucose from previous treatments.

Event Description

It was reported that a patient had a reaction after using bd posiflush¿ xs pre-filled flush syringe.Verbatim: "we have received an adverse event report on (b)(6) 2019 whereby patient concerned was reported to be experiencing nausea and vomiting episodes.Patient concerned attended local hospital - further information has since been obtained from fresnius nursing team to advise the event is not related to parenteral nutrition; but due to patients' underlying condition.Parenteral nutrition was not connected.Product: 306572 pfs p/flush xs saline.Batch: 8270683.Use: 10 ml to flush the line before and 20 ml after each infusion - as directed.Sample: no.Can you please provide your case reference for our records?".

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8433132
• MDR Text Key: 139225794
• Report Number: 9616657-2019-00151
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/08/2019

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?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8270683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention