MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML SALINE 3ML FILL W/BPC; SALINE VASCULAR ACCESS FLUSH

Model Number 306549

Device Problem Volume Accuracy Problem (1675)

Patient Problem Underdose (2542)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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 review could not be completed as no batch number was provided.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the entire flush was not delivered with the syringe 3ml saline 3ml fill w/bpc during use, with only "0.4ml" delivered instead of the "0.6ml" programmed.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "we have recently switched over from having 0.45% normal saline flushes that are prepared in our pharmacy to the 3ml 0.9% normal saline flushes that are from bd.Since the switch i have been getting concerns brought to me from our nursing staff about the entire flush amount not being delivered that was programmed.After a meeting on monday some of the nurses decided to test it out and, from what they were able to measure, only 0.4ml was delivered each time instead of the 0.6ml that was programmed.".

• Brand Name: SYRINGE 3ML SALINE 3ML FILL W/BPC
• 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: 9635047
• MDR Text Key: 195223895
• Report Number: 1911916-2020-00055
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065494
• UDI-Public: 30382903065494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2020

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 Model Number: 306549
• Device Catalogue Number: 306549
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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