MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ 4% SODIUM CITRATE FILL; FLUSH SYRINGE

Catalog Number 303270

Device Problems Volume Accuracy Problem (1675); Free or Unrestricted Flow (2945); Illegible Information (4050)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.303270, batch no.8204589.It was reported that during use of the bd posiflush¿ 4% sodium citrate fill "air entered the syringe again just prior to instilling this to the cvc lumen." in speaking with nurses, other concerns have to do with the label on the syringe.The label is not completely transparent and on most syringes, the label is irregularly bubbled in its application on the syringe and if the bubbling of the label occurs where the graduations are, it is more challenging to ensure correct volume of administration.The following information was provided by the initial reporter: we have implemented the use of the bd sodium citrate syringes in our hemodialysis program.I recently had the opportunity to use the posiflush citrate syringe and i found that after expelling the air and excess na citrate from the syringe (we instill 2.5ml to each lumen), i noticed that air entered the syringe again just prior to instilling this to the cvc lumen.I discussed with our epl, and a few other nurses have raised this concern.Vac, and i met yesterday to review our use of the posiflush syringe and to try and recreate this in simulation, and there may have been a negligible amount of air enter the tip, but not what i had experienced with first use.

Manufacturer Narrative

H.6.Investigation: five representative samples were received.The packaging flow wrap was removed from each sample.Visual inspection was performed finding the barrel label in its correct position.The barrel label application is also correct.Nothing wrong was observed on the barrel label with regards to transparency.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

Material no.303270, batch no.8204589.It was reported that during use of the bd posiflush¿ 4% sodium citrate fill "air entered the syringe again just prior to instilling this to the cvc lumen." in speaking with nurses, other concerns have to do with the label on the syringe.The label is not completely transparent and on most syringes, the label is irregularly bubbled in its application on the syringe and if the bubbling of the label occurs where the graduations are, it is more challenging to ensure correct volume of administration.The following information was provided by the initial reporter: we have implemented the use of the bd sodium citrate syringes in our hemodialysis program.I recently had the opportunity to use the posiflush citrate syringe and i found that after expelling the air and excess na citrate from the syringe (we instill 2.5ml to each lumen), i noticed that air entered the syringe again just prior to instilling this to the cvc lumen.I discussed with our epl, and a few other nurses have raised this concern.Vac, and i met yesterday to review our use of the posiflush syringe and to try and recreate this in simulation, and there may have been a negligible amount of air enter the tip, but not what i had experienced with first use.

• Brand Name: BD POSIFLUSH¿ 4% SODIUM CITRATE FILL
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8656055
• MDR Text Key: 147514313
• Report Number: 1911916-2019-00544
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 303270
• Device Lot Number: 8204589
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other