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

Model Number	306549
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9635047
• Report Number: 1911916-2020-00055
• Device Sequence Number: 14175629
• Product Code: NGT
• UDI-Device Identifier: 30382903065494
• UDI-Public: 30382903065494
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 306549
• Device Catalogue Number: 306549
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other