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

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Swelling (2091)

Event Date 01/15/2019

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 bd posiflush¿ xs pre-filled flush syringe nacl was used after patient was experiencing shortness of breath and had slight swelling to ankles.The following information was provided by the initial reporter: we have been informed of the following adverse event on (b)(6) 2019 whereby patient concerned requested nursing visits as unable to manage procedures; the patient was reported to have been experiencing shortness of breath.Patient advised attended local gp ((b)(6) 2019) and had been prescribed furosemide and a cardiology referral.Patient advised had some slight swelling to ankles; hence went to gp.No further information has been obtained on patients' outcome following course of antibiotic.Product: 306572 pfs 0.9% p/flush xs saline 10ml st; batch: 8242797; sample: no samples available; use: as directed.

Event Description

It was reported that bd posiflush¿ xs pre-filled flush syringe nacl was used after patient was experiencing shortness of breath and had slight swelling to ankles.The following information was provided by the initial reporter: we have been informed of the following adverse event on 15 jan 2019 whereby patient concerned requested nursing visits as unable to manage procedures; the patient was reported to have been experiencing shortness of breath.Patient advised attended local gp (15 jan 2019) and had been prescribed furosemide and a cardiology referral.Patient advised had some slight swelling to ankles; hence went to gp.No further information has been obtained on patients' outcome following course of antibiotic.Product: 306572 pfs 0.9%p/flush xs saline 10ml st.Batch: 8242797.Sample: no samples available.Use: as directed.

Manufacturer Narrative

Dhr was completed and no non-conformances were seen for this batch that could contribute to the complaint reported.Neither sample nor photo were 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.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8514281
• MDR Text Key: 141941986
• Report Number: 9616657-2019-00183
• 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: 04/30/2019

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: 8242797
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention