MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SYRINGE 3 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306544
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one photo was provided.It shows one case box for heparin product with the right label- catalog number- lot number.The shelf boxes inside the case box are correctly labeled; however, they are saline flush products.Most probably root cause is that a case box for heparin products got mixed with the boxes for saline products.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.Investigation conclusion: this is the first complaint for the lot# 8353601 for the same defect or symptom.There was no documentation of issues for the complaint of batch # 8353601 during this production run.Root cause description: most probably root cause is that a case box for heparin products got mixed with the boxes for saline products.
Event or Problem Description
It was reported that bd posiflush¿ sp syringe 3 ml had incorrect label information.This was discovered before use.The following information was provided by the initial reporter: material no: 306544, batch no: 8353601.It was reported that the outside cardboard box says "heparin" but the white boxes inside have the correct labeling of the saline syringes.Injuries or adverse event: no.Item: 306544.Quantity affected: 5 cs.Are any samples available for return? yes.Reported issue: the brown cardboard box says heparin, but the white boxes on the inside don¿t.Customer wants to know if this is an issue.Customer disposition request: replacement.White boxes on the inside looked like they should saline flush syringe.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE 3 ML
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8727819
• Report Number: 1911916-2019-00621
• Device Sequence Number: 1729800
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/10/2019

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: 12/31/2021
• Device Catalogue Number: 306544
• Device Lot Number: 8353601
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/24/2019
• 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