MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; FLUSH SYRINGE

Catalog Number 306595

Device Problem Positioning Problem (3009)

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

Event Date 09/20/2018

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 with the use of the 10 ml bd posiflush¿ normal saline syringe there was an issue with plunger movement difficult.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.One sample was received with no sealed packaging flow wrap.It has the plunger rod-rubber stopper, the tip cap, no saline solution and the barrel label confirms the lot# 7269598.The rubber stopper is at the 4ml mark.The sample was tested for sustaining force.It measured 17.45n which is within specification.After the first test the plunger rod was pulled up to the 10ml mark and tested again giving a sustaining force of 17.40n.Product spec for sustaining force <20n.Failure mode was not verified.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.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.

Event Description

It was reported with the use of the 10 ml bd posiflush¿ normal saline syringe there was an issue with plunger movement difficult.There was no report of injury or medical intervention.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7965414
• MDR Text Key: 123821407
• Report Number: 1911916-2018-00555
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K982558
• 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: 10/24/2018

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7269598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other