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

Catalog Number 306547

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/26/2018

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 bd posiflush¿ normal saline syringe there was an issue with plunger detaching from the rubber stopper during use.

Event Description

It was reported with the use of the bd posiflush¿ normal saline syringe there was an issue with plunger detaching from the rubber stopper during use.

Manufacturer Narrative

H.6.Investigation summary: one sample was received for evaluation.The plunger rod-rubber stopper is all the way down.The plunger rod is not assembled to the rubber stopper, therefore failure mode is verified.They were removed to perform a visual inspection.The plunger rod threads show no damages or any other defect, the rubber stopper inner threads are also not defective, nor damaged.They were assembled just two threads out of the five and pulled up, they stayed together.Root cause is undetermined.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.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8279054
• MDR Text Key: 134208624
• Report Number: 1911916-2019-00113
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 306547
• Device Lot Number: 8197794
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other