MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/11/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).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 blood leaked behind the unspecified bd posiflush¿ syringe plunger while flushing the patient's dialysis catheter.This complaint was created to capture the 5th of 12 related incidents.The following information was provided by the initial reporter: "10ml syringe used to flush patient's dialysis catheter allowed blood to get behind the plunger.".

Event Description

It was reported that blood leaked behind the unspecified bd posiflush¿ syringe plunger while flushing the patient's dialysis catheter.This complaint was created to capture the 5th of 12 related incidents.The following information was provided by the initial reporter: "10ml syringe used to flush patient's dialysis catheter allowed blood to get behind the plunger.".

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.

• Brand Name: UNSPECIFIED BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8646451
• MDR Text Key: 146357790
• Report Number: 2243072-2019-01024
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 06/19/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other