MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE FLUSH SYRINGE

Catalog Number 306572

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067); Tachycardia (2095); Reaction (2414)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that after use of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% there was a reaction.On (b)(6) 2019 patient concerned was experiencing a high temperature; highest recorded 38.9c.Nurse reported patients' pulse is weak and fast.Nurse advised, the patient concerned was discharged from hospital on (b)(6) 2019 following 10 days of iv antibiotic therapy for sepsis and line infection.Patient advised to attend a&e - no further information has been obtained pertaining to patients' outcome following a&e admission.

Event Description

It was reported that after use of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% there was a reaction.On (b)(6) 2019 patient concerned was experiencing a high temperature; highest recorded 38.9c.Nurse reported patients' pulse is weak and fast.Nurse advised, the patient concerned was discharged from hospital on (b)(6) 2019 following 10 days of iv antibiotic therapy for sepsis and line infection.Patient advised to attend a&e - no further information has been obtained pertaining to patients' outcome following a&e admission.

Manufacturer Narrative

Investigation summary: dhr: the non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute to the complaint reported by the customer.No sample available.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 (b)(4) 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 0.9%
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8439883
• MDR Text Key: 139442347
• Report Number: 9616657-2019-00157
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8242797
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention