MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306575

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 nausea, vomiting, and bad taste occurred during use with 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter, "during a consultation with home-tpn patients i received feedback that a patient became nauseous / vomited while flushing with the pre-filled saline syringes of bd.She doesn't want to use this anymore, only the mini puddles with nacl 0,9%.There was a second report of nausea and vomiting, this patient asked immediately after flushing with saline for medication for the nausea.Have there been any reports of this from other hospitals? any link with saline? it also strikes me that more patients mention the (bad) taste during rinsing with the posiflush.This is not conducive to patients who try to start up a normal diet again after a chemotherapy treatment.The saline gives them a bad taste in the mouth which does not promote appetite.There are already articles about experiencing bad taste (smell), it is not new but has the company done anything to reduce this discomfort? if not, what complicates this? changing certain compositions? customer responded that the complaint is general and it concerns several lot numbers.He gives as example: bd posiflush sp syringe 0.9% sodium chloride (0.9% nacl) 10ml, ref: 306575, lot 8017730.".

Event Description

It was reported that nausea, vomiting, and bad taste occurred during use with 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter, "during a consultation with home-tpn patients i received feedback that a patient became nauseous / vomited while flushing with the pre-filled saline syringes of bd.She doesn't want to use this anymore, only the mini puddles with nacl 0,9%.There was a second report of nausea and vomiting, this patient asked immediately after flushing with saline for medication for the nausea.Have there been any reports of this from other hospitals? any link with saline? it also strikes me that more patients mention the (bad) taste during rinsing with the posiflush.This is not conducive to patients who try to start up a normal diet again after a chemotherapy treatment.The saline gives them a bad taste in the mouth which does not promote appetite.There are already articles about experiencing bad taste (smell), it is not new but has the company done anything to reduce this discomfort? if not, what complicates this? changing certain compositions? customer responded that the complaint is general and it concerns several lot numbers.He gives as example: bd posiflush sp syringe 0.9% sodium chloride (0.9% nacl) 10ml ref: 306575.Lot 8017730".

Manufacturer Narrative

Investigation summary: bd has been provided with a sample for catalog 306575 lot 8017730 to investigate for this record.A review of the device history record revealed no irregularities during the manufacture of the reported lot.A single syringe, without flow wrap was visually examined and looks like the sample has not been used and is a representative sample from the batch.Icp from heavy metals detection was performed on the received.Results obtained do not exceed the established limited for posiflush pre-filled syringes and do not show any abnormality.As a result, bd was unable to verify the reported issue.Dysgeusia has been the subject of a series of in-depth investigations by bd.In addition to biocompatibility testing, bd has conducted extensive chemical, biochemical, analytical and biological testing of relevant materials.These investigations confirmed the absence of any significant risk to the patient¿s health following single or repeated exposure to bd posiflush¿ syringe contents.It was concluded that while unpleasant to the patient, this effect has no clinically relevant medical consequences.Bd posiflush¿ syringes continue to meet or exceed all standards applicable to these syringes.No corrective action is required.This log number and incident will be monitored for identification of emerging trends and for future occurrence in order to driving appropriate corrective and preventive actions.

• Brand Name: 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8834185
• MDR Text Key: 152498550
• Report Number: 3002682307-2019-00415
• 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: 09/10/2019

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?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 306575
• Device Lot Number: 8017730
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention