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

Catalog Number 306595

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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 the bd posiflush¿ normal saline syringe plunger was "difficult to push".

Manufacturer Narrative

Correction: describe event or problem: it was reported that the bd posiflush¿ normal saline syringe plunger was "difficult to push".This occurred on 9 separate occasions but the date/time and or patient information is unknown.Investigation summary: 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 record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that the bd posiflush¿ normal saline syringe plunger was "difficult to push".This occurred on 9 separate occasions but the date/time and or patient information is unknown.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8189901
• MDR Text Key: 131338992
• Report Number: 1911916-2018-00763
• 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: 01/15/2019

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: 02/28/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8046825
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other