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

Catalog Number 306572

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Pain (1994)

Event Date 12/29/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8242797.Medical device expiration date: 2021-08-31.Device manufacture date: 2018-08-30.Medical device lot #: 8270683.Medical device expiration date: 2021-08-31.Device manufacture date: 2018-09-27.(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 a bd posiflush¿javascript: resizeflexelement ('describe event or problem', 'describe event or problem', false, false) xs pre-filled flush syringe nacl 0.9% was involved with a patient that received nutrition infusions, experiencing pain and nausea from the infusions.The following was reported, we have received an adverse event reported on (b)(6) 2019 to advise patient unwell; nausea.Nurse reported patient has long standing issues of experiencing pain and nausea from parenteral nutrition infusions, patient advised to seek advice from hospital; no further information obtained.

Manufacturer Narrative

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.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.H3 other text : see section h.10.

Event Description

It was reported that a bd posiflush¿javascript:resizeflexelement('describe event or problem', 'describe event or problem', false, false) xs pre-filled flush syringe nacl 0.9% was involved with a patient that received nutrition infusions, experiencing pain and nausea from the infusions.The following was reported, " we have received an adverse event reported on 29 dec 2018 and 13 jan 2019 to advise patient unwell; nausea.Nurse reported patient has long standing issues of experiencing pain and nausea from parenteral nutrition infusions, patient advised to seek advice from hospital; no further information obtained.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8440352
• MDR Text Key: 139472889
• Report Number: 9616657-2019-00158
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 04/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention