MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 5ML SALINE 5ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306545
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one photo was provided.It shows a case box labeled as 306545- 5ml saline product- with heparin shelf boxes.The line that produced the lot # 9051627 only produces saline products.The shelf boxes are incorrect.Possible root cause is in the packaging area due to mixed material.The heparin shelf boxes were used to packaged saline product; case pack operators have been trained to verify the production order material list with the material to be used.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Investigation conclusion: one photo was provided.It shows a case box labeled as 306545- 5ml saline product- with heparin shelf boxes.The line that produced the lot # 9051627 only produces saline products.Root cause description: possible root cause is in the packaging area due to mixed material.The heparin shelf boxes were used to packaged saline product; case pack operators have been trained to verify the production order material list with the material to be used.
Event or Problem Description
It was reported that label error occurred before use with a syringe 5ml saline 5ml fill.The following information was provided by the initial reporter, "the label on the shipping box did not match what was on the product box received.Opened box of 5 ml saline flushes manufacturer reorder #306545.Heparin flushes were inside the box.The box was sealed.".

• Brand Name: SYRINGE 5ML SALINE 5ML FILL
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9136117
• Report Number: 1911916-2019-01030
• Device Sequence Number: 14133726
• Product Code: NGT
• UDI-Device Identifier: 30382903065456
• UDI-Public: 30382903065456
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/16/2019

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: 01/31/2022
• Device Catalogue Number: 306545
• Device Lot Number: 9051627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/30/2019
• 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