MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number	306544
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2018
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 with the use of the bd posiflush¿ normal saline syringe there was an issue with label containing a qr code instead of a regular bar code.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.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 was reported with the use of the bd posiflush¿ normal saline syringe there was an issue with label containing a qr code instead of a regular bar code.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Common Device Name: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8203338
• Report Number: 1911916-2018-00806
• Device Sequence Number: 13943225
• Product Code: NGT
• UDI-Device Identifier: 00382903065448
• UDI-Public: 00382903065448
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141311
• 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): 01/03/2019

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 Catalogue Number: 306544
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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