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

Catalog Number 306572

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Swelling (2091); Reaction (2414)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Other occupation: qa officer & deputy nso (medical devices & enteral nutrition).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 developed an allergic reaction, including face swelling and some difficulty breathing, while connected to the bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.It was also reported that the patient was prescribed "prednisone (04 day course)" and "discharged with no follow up planned".

Event Description

It was reported that the patient developed an allergic reaction, including face swelling and some difficulty breathing, while connected to the bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.It was also reported that the patient was prescribed "prednislone (04 day course)" and "discharged with no follow up planned".

Manufacturer Narrative

H.6.Investigation: during review of the dhr 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.No sample was returned for testing.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 0.9%
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8311262
• MDR Text Key: 135342262
• Report Number: 9616657-2019-00113
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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: 8242797
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention