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

Catalog Number	306507
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/15/2018
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 a few bd¿ pre-filled normal saline syringes had a "milky substance" in them.
Additional Manufacturer Narrative
Investigation summary: one hundred and eleven samples belonging to lot number: 805211c were received for evaluation by our quality engineer team for the defect of foreign matter.A device history record review did not reveal any detected non-conformances during the production of lot number: 805211c.Out of the one hundred and eleven samples, a white substance was observed within one opened sample.An additional one hundred and twenty retained samples of the same lot number were visually inspected and no signs of foreign matter were observed.A small portion of the substance was removed and fourier transform infrared (ftir) spectroscopy was performed.The spectral analysis revealed that the material had a strong match to fluorosilicone fluid.The exact cause of the foreign matter identified is unknown.The fluorosilicone fluid is not used or manufactured at the bd franklin facility therefore, it is believed to have originated from the syringe supplier.A supplier corrective action request has been submitted to the syringe supplier for this issue, in order to further determine the origin of the fluid identified.The results will be tracked and reviewed within bd franklin's next management review meeting.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.Due to the low occurrence of this defect, no further actions will be taken at the bd franklin facility.
Event or Problem Description
It was reported that a few bd¿ pre-filled normal saline syringes had a "milky substance" in them.

• Brand Name: BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 8137951
• Report Number: 2134319-2018-00116
• Device Sequence Number: 1106824
• Product Code: FOZ
• UDI-Device Identifier: 30382903065074
• UDI-Public: 30382903065074
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/19/2018

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: 02/20/2021
• Device Catalogue Number: 306507
• Device Lot Number: 805211C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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