MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD; 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	09/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility: the user facility address is not available, the corporate headquarters information was used instead.Investigation summary: one sample was received.It has the plunger rod-rubber stopper, no tip cap, and it has 3ml of saline solution; the rubber stopper is at 4.5ml.The plunger rod was removed from the syringe.No manufacturing issues were experienced during the production of these products.The barrel has a retaining ring at the inner barrel wall so the plunger rod stops at that point.The plunger rod was assembled back into the syringe and verified the performance pushing the plunger rod down.It worked with no issues.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.Possible root cause, off label use.The syringe is designed to flush the iv lines by pushing the plunger rod down, not to pull the plunger rod up and removing it from the syringe.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.
Event or Problem Description
It has been reported that one syr 10 ml fil saline shortlength plunger rod has been found with stopper separation from the plunger during use.The following has been provided by the initial reporter: it was reported that the plunger rod separated from the stopper and pulled out of the syringe.Event description per attached email states: date of occurrence: (b)(6) 2019.Product item number: 306499.Lot number: 9002663.Description: ¿plunger pulled out of flush.

• Brand Name: SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9203746
• Report Number: 1911916-2019-01100
• Device Sequence Number: 19346811
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: Other
• 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: 10/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/17/2019
• 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