MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD; INTERVASCULAR CATHETER

Catalog Number 306499

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Root cause description: no root cause can be determined as no samples were received.

Event Description

It was reported that occlusion alarms occurred with syr 10 ml fil saline short length plunger rods on the mini pumps.The following information was provided by the initial reporter, "it was reported that the 10ml flushes are causing occlusion alarms on mini pumps.One of our staff just brought to my attention that the new 10ml flushes are reading occlusion on the mini pumps, as experienced by at least 3 people.I didn't know if you had this brought to your attention, or if there is another avenue that i should be exploring to investigate this.I asked the nurse to fill out a psor as well so that it can be tracked if this is an ongoing issue.Please let me know if you have already heard of this or if you need more information.Thank you, per email: i met with the unit director and all 10 staff members today.Out of these staff members, only one person, shared that he has an occasional issue with the medfusion 4000 pump pressure alarming when he uses the item #306499 on the pump after diluting medication in the flush syringe first.He states that he purges some of the flush from the flush syringe, draws up some medication (benadryl was an example he used) and injects the medication into the flush syringe with the remaining flush.He then programs the pump and gets pressure alarms intermittently throughout the infusion.He did say that this does not occur every time." 3 occurrences were reported.

• Brand Name: SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9274140
• MDR Text Key: 195538505
• Report Number: 1911916-2019-01156
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903064992
• UDI-Public: 30382903064992
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306499
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• 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