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

Catalog Number 306594

Device Problems Leak/Splash (1354); Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: 5 photos were provided.The photos show the syringe with no barrel label, the plunger rod damaged and the syringe with a white background.When the machine stops and re starts again it may have a missing barrel label and escaped; there are no additional controls to detect it.At the plunger rod labeler process, there is a sensor which is challenged at the shift start.When the machine stops and restarts again it may have a missing barrel label and escaped and there are no additional controls to detect it.For the plunger rod damaged (it seems like heated), it may have happened at the flow wrapper packaging process.This part was not fully centered and the mechanism that seals the flow wrap damaged it.For the clarity of the solution the sample would be needed for analysis.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: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the photos provided.This is the 1st complaint for lot # 9226696 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: plunger rod labeler process.Flow wrap packaging process.Rationale: capa not required at this time.

Event Description

It was reported that no scale markings were found on the bd posiflush¿ syringe when opening it from the packaging before use.Additionally, the plunger rod appeared to be damaged "by high temperature", and the solution inside appeared to be discolored.The following information was provided by the initial reporter, translated from chinese to english; "it was found that there was no scale on the flush when opened the outer package.The plunger rod of the flush seemed to be damaged by high temperature.The chief nurse suspected that the flushing fluid was turbidity visually.".

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE VASCULAR ACCESS 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 ; 8015652341
• MDR Report Key: 9931554
• MDR Text Key: 188404126
• Report Number: 1911916-2020-00354
• 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: 04/03/2020

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306594
• Device Lot Number: 9226696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• 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