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

Catalog Number 306546

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 bd posiflush¿ normal saline syringe there was an issue with leakage.It was stated ¿when flushing the patient catheter or line, blood became trapped in ridges of the grey plunger and leaked into the plunger side of the syringe.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

A sample was received for evaluation by one of our quality engineers.It came in double plastic bags one of them a ziploc plastic bag type.It has no packaging flow wrap and no tip cap.It has the plunger rod-rubber stopper.The barrel label confirms the lot#7348585.It has blood between the rubber stopper ribs and over the stopper therefore failure mode is verified.There is a small residues of the blood that passed through the stopper to the plunger side.The syringe purpose is to flush the solution into a port; it seems it was used to pull blood.A definitive root cause could not be determined.A device history review was completed and there was no documentation of issues for the complaint of batch 7348585 during this production run.There were no quality notifications issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.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.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7537727
• MDR Text Key: 109229198
• Report Number: 1911916-2018-00267
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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: 12/31/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7348585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other