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

Model Number 306544

Device Problem Short Fill (1575)

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

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.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.Root cause description: undetermined.Rationale: no batch#/sample available.No further investigation required.

Event Description

It was reported that the entire flush is not being delivered with a bd syringe 3ml saline 3ml fill.The following information was provided by the initial reporter: (1 of 3 complaints) it was reported the customer recently switched over from having 0.45% normal saline flushes prepared in the hospital pharmacy to bd 3ml.9% normal saline flushes.Since the switch they have been getting concerns from the 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.Additionally, on 2020-01-27 the bd sales consultant provided the following additional information: what are the lot #¿s used for ref # (b)(4)? we have ndc, not lot numbers.What was the date this incident took place? use 1/15 for the purpose of the report.Are any samples available from each material number to be returned to bd for evaluation? if so a (b)(4) shipping label will be provided.You are welcome to use your own inventory of 3 ml flush syringes.If you would like us to send a 3 ml flush syringe to you we can.Did serious injury occur as a result of this incident? no.Did erroneous results occur on the patient due to this incident? no, but this has the potential to cause harm.Was the course of treatment changed due to event? no.Exposure to blood/bodily fluid? no.Was medical intervention performed other than first aid? no.Was any medical professional harmed by a needle/probe stick? no.Were any other actions taken because of the issue stated? we have started testing the volumes delivered via gravimetric testing using all the syringes we carry.Are any patient identifiers available (i.E.Gender, initials, weight, etc.)? yes, but this is not relevant to what we are discussing.

• Brand Name: BD SYRINGE 3ML SALINE 3ML FILL
• 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: 9648608
• MDR Text Key: 196444415
• Report Number: 1911916-2020-00075
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• 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: other,user facility
• 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

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 306544
• Device Catalogue Number: 306544
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• 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