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

Catalog Number 306565

Device Problem Leak/Splash (1354)

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

Event Date 04/05/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 leakage occurred before use with a bd posiflush¿ saline syringe.The following information was provided by the initial reporter, "deviation: syringe showing leakage.Fact observed with the packaging still closed.".

Event Description

It was reported that leakage occurred before use with a bd posiflush¿ saline syringe.The following information was provided by the initial reporter, "deviation: syringe showing leakage.Fact observed with the packaging still closed.".

Manufacturer Narrative

Additional information d.10 device available for eval: no h.6.Investigation summary a device history review was conducted for lot number 9246445 this is the 1st complaint for lot # 9246445 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Two photos were provided.Both show a syringe with the luer tip bent.This occurs when the syringe is misplaced in the sterilizer tray then the next tray that goes on top lays on top of the misplaced syringe inducing the luer tip damaged.This type of damage occurs when the syringe is not properly placed on the sterilizer trays.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.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.H3 other text : see h.10.

• Brand Name: BD POSIFLUSH¿ 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: 9996992
• MDR Text Key: 189200344
• Report Number: 1911916-2020-00408
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065653
• UDI-Public: 382903065653
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306565
• Device Lot Number: 9246445
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other