MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 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	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of syr 10 ml fil saline shortlength plunger rod experienced stopper separation from the plunger.It has not been specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: material no.: 306499 batch no.: 9018605.Verbatim: i'm not sure what is happening at bd with the manufacturing of their syringes but we are now getting reports of the flushes having problems.The black piece is coming off of the plunger.This is the same problem reported with the 20ml syringe.
Additional Manufacturer Narrative
H.6.Investigation summary: two samples were received.They came in a ziploc plastic bag.They have no packaging flow wrap.One has tip cap and the other one has not.One has the stopper at the 3ml mark and the other one at 5.5ml.Both have the plunger rod, not assembled to the rubber stopper.This could have happened during off label use.The syringe is designed to flush the iv lines by pushing down the plunger rod.The plunger rod shouldn¿t be pulled back.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that an unspecified number of syr 10 ml fil saline shortlength plunger rod experienced stopper separation from the plunger.It has not been specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: material no.: 306499 batch no.: 9018605.Verbatim: i'm not sure what is happening at bd with the manufacturing of their syringes but we are now getting reports of the flushes having problems.The black piece is coming off of the plunger.This is the same problem reported with the 20ml syringe.

• Brand Name: SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9791589
• Report Number: 1911916-2020-00212
• Device Sequence Number: 16780717
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/09/2020

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: 01/31/2022
• Device Catalogue Number: 306499
• Device Lot Number: 9018605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/09/2020
• 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