MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD 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 Problems Nausea (1970); Vomiting (2144)

Event Date 12/09/2018

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 bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used after patient became nauseous and was vomiting (10-12 times) during parenteral nutrition administration.Patient connected to saline (over 12 hours).Patient advise to seek medical advice if symptoms get worse.

Manufacturer Narrative

Investigation summary: dhr: complaint trending review of the lot for this issue reveals this is the fifth 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.No sample available.Conclusion: 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.

Event Description

It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used after patient became nauseaus and was vomiting (10-12 times) during parenteral nutrition administration.Patient connected to saline (over 12 hours).Patient advise to seek medical advice if symptoms get worse.

• Brand Name: BD 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: 8396251
• MDR Text Key: 138014985
• Report Number: 9616657-2019-00134
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8185572
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other