MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ PRE-FILLED NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number	306507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that the nurse found the bd¿ pre-filled normal saline syringe product was not completely filled and there was orange/ brown sediment in the syringe when the sealed package was opened.Found before use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Date received from manufacturer: 03/26/2017.Date received from manufacturer: 03/26/2018.
Additional Manufacturer Narrative
Investigation summary: flks received one 3ml saline syringe with material on the surface of the stopper and floating in the solution in the barrel.As per request, analysis was carried out on this material.A small portion of this material was removed the stopper and prepared for ftir spectral analysis.However, ftir analysis yielded no spectral results indicating that this material may be metallic in nature.This material from the stopper was then tested using sem/edx analysis.The analysis shows that this material is composed of mainly of iron and oxygen which are the main components of rust.Sodium and chlorine could be from the saline solution in the barrel and silicon is from the silicone present on the stopper.Scar/ftir: a single 3ml syringe was observed filled with reportedly saline solution.The solution has turned "rust" color and a piece of fm could be seen on top of the stopper and also floating in the solution.Dhr: all inspections were accepted.No qn's.A scar has been issued to the stopper supplier on 05/03/2018.The stopper supplier c/a will be evaluated by bd canaan upon receipt of the supplier's response.Bd canaan will continue to monitor supplier quality.Franklin investigation: sample received.The sample syringe contained rust sediment floating in solution and attached to the stopper.Also, the 3ml syringe only contained approximately 2.5ml of solution.Dhr: there were no non-conformances, deviations, or issues noted during the manufacture, storage, or distribution of lot# 729111c.Root cause: based on the investigations performed, the root cause of the fm is likely to have originated at the bd canaan stopper supplier.The fm did not originate from the bd franklin filling operations.The root cause of the incorrect fill volume is likely manufacturing related such as a mis fill during filling operations.

• Brand Name: BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: SALINE FLUSH
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7411179
• Report Number: 2134319-2018-00002
• Device Sequence Number: 16152707
• Product Code: FOZ
• UDI-Device Identifier: 00382903065073
• UDI-Public: 00382903065073
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2018

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: Nurse
• Device Expiration Date: 10/17/2020
• Device Catalogue Number: 306507
• Device Lot Number: 729111C
• Initial Date Received by Manufacturer: 03/26/2017
• Supplement Date Received by Manufacturer: 03/26/2018; 03/26/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/17/2018; 05/09/2018
• 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