MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SYRINGE; HEPARIN, VASCULAR ACCESS FLUSH

Model Number	306423
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: it was reported that a brown particulate was found inside the syringe while drawing up the heparin lock flush solution.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe with no packaging flow wrap.The syringe has a brown spot that appears to be embedded degraded resin.No other defects of imperfections were observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.As the lot provided is 'unknown,' a device history record review could not be completed.Verification of the molding process was performed.The settings were correct and the flow of products was good.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd posiflush syringe contained foreign matter.The following information was provided by the initial reporter: "one syringe was found on saturday 10/2/21 with brown particulate on the inside of the syringe barrel.".

• Brand Name: BD POSIFLUSH SYRINGE
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12736712
• Report Number: 1911916-2021-01131
• Device Sequence Number: 14829013
• Product Code: NZW
• UDI-Device Identifier: 30382903064237
• UDI-Public: 30382903064237
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 306423
• Device Catalogue Number: 306423
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1