MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD TWINPAK DUAL CANNULA DEVICE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303390
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacture date: unknown.Investigation results summary: a total of ten (10) samples were received.They were visually inspected under the microscope 30x finding no black specs or any other type of foreign matter or defect.A device history review could not be completed as no batch number was provided.Conclusion/root cause description: bd was able to duplicate or confirm the customer¿s indicated failure mode.Based on the investigation conclusion the definitive root cause could not be determined.
Event or Problem Description
It was reported that on two (2) occurrences foreign matter was found on a bd twinpak¿ dual cannula before use.The following information was reported in the event description: it was reported black specs were found in the medication when inside the barrel.Per phone call: in their gi department they discovered black specs inside the syringe when drawing up medication.They tried with another syringe with a different medication and same thing occurred.They tested with saline and it was clean.First time this has occurred.Unsure which lot specifically.Can provide photos and representative samples.

• Brand Name: BD TWINPAK DUAL CANNULA DEVICE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9772165
• Report Number: 1911916-2020-00201
• Device Sequence Number: 3040708
• Product Code: FMI
• UDI-Device Identifier: 30382903033905
• UDI-Public: 30382903033905
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: Health Professional
• Device Model Number: 303390
• Device Catalogue Number: 303390
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/28/2020
• 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