MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LS S/C 56; PISTON SYRINGE

Catalog Number	302833
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the syringe 30ml ls s/c 56 experienced foreign matter contamination.The following information has been provided by the customer: verbatim: ¿nurse found the barrel with foreign matter before using.¿ see pr for additional details.Complaint summary detail: this is mdr reportable.If foreign matter particles are in the fluid path or on the cannula it may have the potential to enter the blood stream of an individual and possibly cause harm i.E.Embolism, infection, etc.Event type: foreign matter / malfunction.
Event or Problem Description
It was reported that the syringe 30ml ls s/c 56 experienced foreign matter contamination.The following information has been provided by the customer: verbatim: ¿nurse found the barrel with foreign matter before using.¿ see pr for additional details.Complaint summary detail: this is mdr reportable.If foreign matter particles are in the fluid path or on the cannula it may have the potential to enter the blood stream of an individual and possibly cause harm i.E.Embolism, infection, etc.Event type: foreign matter / malfunction.
Additional Manufacturer Narrative
Investigation summary: one sample and two photos were received for evaluation.The sample has embedded 7 spots with burnt plastic embedded in the barrel wall.The photos show the embedded foreign matter.Burns can be caused when there is blockage in the mold vents/ gates which can cause burns on the flange of the syringe during molding process.Embedded foreign matter can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the mold and press.The degraded resin can break loose and be molded into components.This is a cosmetic defect only and does not affect the integrity of 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.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.

• Brand Name: SYRINGE 30ML LS S/C 56
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8413446
• Report Number: 1911916-2019-00259
• Device Sequence Number: 16591748
• Product Code: FMF
• UDI-Device Identifier: 30382903028338
• UDI-Public: 30382903028338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 07/31/2022
• Device Catalogue Number: 302833
• Device Lot Number: 7179512
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 03/20/2019
• 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