MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD¿ PRE-FILLED NORMAL SALINE SYRINGE; FLUSH

Catalog Number 306593

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was provided.It shows a syringe with packaging flow wrap, plunger rod-rubber stopper, tip cap, saline solution and no barrel label.This would have occurred due to a variation in the plunger rod labeler machine.The vision system is challenged at the beginning of every shift.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.Investigation conclusion: this is the 1st complaint for lot # 8299934 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: this would have occurred due to a variation in the plunger rod labeler machine.Rationale: the vision system is challenged at the beginning of every shift.

Event Description

It has been reported that one bd¿ pre-filled normal saline syringe has been found missing scale markings during use.The following has been provided by the initial reporter: the patient came to the hospital due to inactivity of the left limb for 4 hours.After admission, the patient received infusion according to the doctor's advice.After the infusion, when the indwelling needle was placed to seal the tube, it was found that flush had no scale and was replaced with a new one, which did not cause adverse consequences to the patient.

• Brand Name: BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9384204
• MDR Text Key: 192237938
• Report Number: 1911916-2019-01255
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 306593
• Device Lot Number: 8299934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2018
• 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