MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306547

Device Problems Leak/Splash (1354); Illegible Information (4050)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd posiflush¿ normal saline syringe leaked past the plunger during use.Additionally, it was reported that the syringe was "near impossible" to scan.The following information was provided by the initial reporter: "i am just reaching out to you regarding the prefilled saline syringe category.I know that bd had a team here in our dialysis department to try to replicate the issue with the leaking plunger that has been reported.From my understanding, the practice was not able to replicate these issues when the bd team was here but the practice has informed me that they have continued to have issues.They have even reported that this may be happening more frequently now." we did get reports that the bd prefilled syringe is near impossible to scan into the medical record.It was reported that at times if they put something in the background it will sometimes scan but overall is an ongoing issue.The bigger barcode on the product was reported to be scanned with no issues.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.No root cause can be determined as no samples were received.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see section h.10.

Event Description

It was reported that the bd posiflush¿ normal saline syringe leaked past the plunger during use.Additionally, it was reported that the syringe was "near impossible" to scan.The following information was provided by the initial reporter: "i am just reaching out to you regarding the prefilled saline syringe category.I know that bd had a team here in our dialysis department to try to replicate the issue with the leaking plunger that has been reported.From my understanding, the practice was not able to replicate these issues when the bd team was here but the practice has informed me that they have continued to have issues.They have even reported that this may be happening more frequently now." we did get reports that the bd prefilled syringe is near impossible to scan into the medical record.It was reported that at times if they put something in the background it will sometimes scan but overall is an ongoing issue.The bigger barcode on the product was reported to be scanned with no issues.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9667938
• MDR Text Key: 190513130
• Report Number: 1911916-2020-00093
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other