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	09/12/2018
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 with the use of the 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe there was an issue with leakage.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
A device history record review did not find any deviations, non-conformances, or out of specification conditions during the production of lot number 807911a.As samples were unavailable for return, one-hundred and twenty retained samples of the same lot number were obtained from the manufacturing facility for investigation.Through visual inspection of the retained samples, no signs of leakage were observed.Based on the investigation results, a definite cause for the reported incident could not be determined.As this is the first occurrence for this defect on lot number 807911a, corrective action has not been determined necessary at this time.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.The risk management documents, fran-pfmea-o3 rev 07 includes the failure mode for leakage.The existing conditions, controls, hazards, and ratings do not require updates at this time.There were no returned samples or photos to evaluate.Root cause could not be determined from the customer verbatim.
Event or Problem Description
It was reported with the use of the 10 ml bd pre-filled normal saline syringe, in 10 ml syringe there was an issue with leakage.There was no report of injury or medical intervention.

• 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: 7931173
• Report Number: 2134319-2018-00115
• Device Sequence Number: 1499921
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: Lay User/Patient
• Device Expiration Date: 03/19/2021
• Device Catalogue Number: 306500
• Device Lot Number: 807911A
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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