MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 10ML SHORT PR SALINE 10ML FILL; INTRAVASCULAR CATHETER

Catalog Number	306499
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one sample was received.It has no packaging flow wrap and has the plunger rod-rubber stopper and no solution.It has no tip cap, the rubber stopper is at 1ml.There is no separation between the rubber stopper and the plunger rod.No manufacturing issues were experienced during the production of these products.The posiflush sp syringe is designed to flush the iv line, is not designed to pull the plunger rod back.The defect was not confirmed and the root cause could not be determined.At this time, no corrective actions are necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.Root cause description: root cause_ off label use.The posiflush sp syringe is designed to flush the iv line.Not to pull the plunger back and draw blood.
Event or Problem Description
It was reported that while flushing central line, pulled back plunger to check for blood return and the stopper separated from the plunger with a bd syringe 10ml short pr saline 10ml fill.The following information was provided by the initial reporter: rn was flushing central line with 10ml ns flush and pulling back to check for a blood return.While pulling back, the plunger disconnected from the black stopper, maintaining the saline in the syringe but not allowing rn to continue flushing.

• Brand Name: BD SYRINGE 10ML SHORT PR SALINE 10ML FILL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9256009
• Report Number: 1911916-2019-01137
• Device Sequence Number: 3461707
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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 Expiration Date: 12/31/2021
• Device Catalogue Number: 306499
• Device Lot Number: 9002663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/30/2019
• 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