MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SF SALINE SYRINGE; 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	10/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one sample was received.It came in a plastic ziploc bag with no packaging flow wrap.It has the plunger rod-rubber stopper, no tip cap, and 4.5 ml of solution.The barrel label confirms the lot#.It came with a 3 way connector.One of the connections has the luer tip that broke off.This defect was reproduced by connecting the 3 way connector to a syringe.Over tightening the syringe breaks the luer tip.No manufacturing issues were experienced during the production of these products.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.Investigation conclusion: 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 overtight when use.Rationale: no manufacturing issues were experienced during the production of these products.The symptom can be reproduced by over tightening the syringe to the 3 way connector.
Event or Problem Description
Material no.: 306499 batch no.: 9002664.It was reported that during use of the bd posiflush¿ sf saline syringe the syringe tip broke off in the stop cock.The following information was provided by the initial reporter: ¿syringe tip broke off in the stop cock.I don¿t think it had anything to do with the amount of force i was using, no more force used than normal.This occurred after the arterial line change and when we went to remove the syringe from the stopcock after drawing labs on an open system arterial line.I went to exchange the syringe to put an empty one on to draw my labs.When twisting off the full ns syringe the tip broke off.I was not drawing back at the time simply twisting off the syringe.Hope this helps.I have an arterial line frequently and this had never happened before.¿.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9290247
• Report Number: 1911916-2019-01165
• Device Sequence Number: 16729651
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/22/2019

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: 9002664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/07/2019
• 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