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

Catalog Number 306574

Device Problem Break (1069)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a photo was received for evaluation the plunger rod is damaged on the top part where the thumb press is therefore failure mode is verified.This type of damage most likely was induced by having the syringe misplaced on the flow wrapper.The sensor verifying the syringe is placed in the right position was challenged and it passed.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 first complaint for lot # 8047790 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.A photo was received for evaluation.It has no packaging flow wrap, it has the plunger rod-rubber stopper, the tip cap, the saline solution and the barrel label; confirms the lot# 8047790.The plunger rod is damaged on the top part where the thumb press is.Root cause description this type of damage most likely was induced by having the syringe misplaced on the flow wrapper.The sensor verifying the syringe is placed in the right position was challenged, it pass.Rationale the sensor verifying the syringe is placed in the right position was challenged and it passed.

Event Description

It was reported that before use of the bd posiflush¿ saline syringe the syringe was in fragments.

• Brand Name: BD POSIFLUSH¿ 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: 8191454
• MDR Text Key: 131311516
• Report Number: 1911916-2018-00787
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K011982
• 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: 12/12/2018

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: 02/28/2021
• Device Catalogue Number: 306574
• Device Lot Number: 8047790
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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