MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 5ML HEPARIN 10 UNIT; INTRAVASCULAR CATHETER

Catalog Number	306414
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo was received.The photo shows two saline syringes and two heparin syringes.Two have the udi 1.0 linear bar code and two the udi 2.0 bar code.The udi 2.0 bar code 2.0 was implemented and the customer was not ready to scan it.Posiflush marketing was informed about this issue.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 1st complaint for the lot# 827566n for the same defect or symptom.There was no documentation of issues for the complaint of batch #827566n during the production run.Root cause description: the udi 2.0 bar code 2.0 was implemented and the customer was not ready to scan it.Posiflush marketing was informed about this issue.
Event or Problem Description
It was reported that a unspecified bd syringe had labeling error.The following was reported, "material no.Unknown, batch no.Unknown.It was reported the heparin locks no longer have barcodes on them."good afternoon, we have been noticing our heparin and ns flushes no longer have barcodes on them? are we ordering the wrong products or is this a permanent change? thanks.".

• Brand Name: SYRINGE 5ML HEPARIN 10 UNIT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8471652
• Report Number: 1911916-2019-00336
• Device Sequence Number: 1473938
• Product Code: NZW
• UDI-Device Identifier: 30382903064145
• UDI-Public: 30382903064145
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 306414
• Device Lot Number: 827566N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/01/2019
• 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