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

Catalog Number 306572

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

Patient Problem Fever (1858)

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, a supplemental report will be filed.

Event Description

It was reported that the patient had fever when discontinuing of parenteral nutrition on the morning of (b)(6) 2019.A d posiflush¿ xs pre-filled flush syringe nacl 0.9% was used to flush for this patient.

Manufacturer Narrative

Investigation: complaint trending review of the lot for this issue reveals this is the first complaint.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.In addition, the retain samples were obtained and repeat endotoxin testing was performed on samples.All results were within the acceptance criteria.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 the patient had fever when discontinuing of parenteral nutrition on the morning of (b)(6) 2019.A d posiflush¿ xs pre-filled flush syringe nacl 0.9% was used to flush for this patient.

• Brand Name: D POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8283793
• MDR Text Key: 134303590
• Report Number: 9616657-2019-00106
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8270683
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other