MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number	306500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
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 that there was an impurity peak within 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringes and the sterility was questioned.The syringes were used to dilute sterile radiopharmaceutical products and an impurity peak was observed on the hplc analysis of the final product.
Event or Problem Description
It was reported that there was an impurity peak within 10 ml bd pre-filled normal saline syringe, in 10 ml syringes and the sterility was questioned.The syringes were used to dilute sterile radiopharmaceutical products and an impurity peak was observed on the hplc analysis of the final product.
Additional Manufacturer Narrative
Twenty-two physical samples of lot number 804711d were returned for evaluation by our quality engineer.A device history record review did not reveal any deviations, non-conformances, or out of specification conditions related to the manufacture of lot number 804711d.One-hundred and twenty retained samples of the same lot number were obtained from the manufacturing facility for further investigation.All of the retained samples were visually inspected and no growth was seen within the solution.The returned samples could not be tested as the storage and shipping conditions of the samples were unknown.This is the first complaint related to an impurity peak for (b)(4) and lot number 804711d.There is currently no trend related to this issue in regards to product manufactured within this designated bd location.Previously, an increase in reported infection cases initiated a corrective and preventive action plan.Through the infection related correction action, a direct cause between the infections and the bd franklin product was not identified.A review of the lot sterility testing performed for lot number 804711d confirmed that no organism growth was identified prior to lot release.The current risk management documents include details for sterile and non-sterile product.The existing conditions, controls, hazards, and ratings do not require updates at this time.Based on the investigation results, a cause for the reported incident could not be identified.Based on the investigation and the low occurrence of this defect, corrective actions are not necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.There were no other complaints reported for impurity peak on a customer's hplc.Note: (b)(4) was initiated due to infection reported cases however this does not appear to be related.The root cause analysis of the reported infection cases under (b)(4) has not identified a direct causation between the infections and the bd franklin product.

• Brand Name: 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Common Device Name: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7874764
• Report Number: 2134319-2018-00114
• Device Sequence Number: 16735806
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• 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): 10/16/2018

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: Other
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 306500
• Device Lot Number: 804711D
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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