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

Catalog Number	306500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
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 during use a bd¿ pre-filled normal saline filled flush syringe was found with foreign matter "a white string of floating debris in the flush." there was no report of exposure, injury or medical intervention needed.
Event or Problem Description
It was reported that during use a bd¿ pre-filled normal saline filled flush syringe was found with foreign matter "a white string of floating debris in the flush." there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
One sample unit containing foreign matter was received for evaluation by our quality engineer team.A small portion of the foreign material was removed from the syringe and prepared for fourier transform infrared spectroscopy (ftir) analysis.The ftir analysis results determined that the material is most likely cellulose along with some saline solution and silicone.A device history record review did not reveal any deviations or non-conformances during the production of lot number 801711d that could have contributed to the presence of foreign matter.The origin of the foreign material could not be determined.As there is no current trend for foreign matter and bd franklin products, this was determined to be an isolated incident.Investigation conclusion: the root cause of the foreign matter found within the syringe was unable to be determined based on the investigation performed.
Event or Problem Description
It was reported that during use a bd¿ pre-filled normal saline filled flush syringe was found with foreign matter "a white string of floating debris in the flush." there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

• Brand Name: BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 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: 7593545
• Report Number: 2134319-2018-00052
• Device Sequence Number: 283543
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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: 01/16/2021
• Device Catalogue Number: 306500
• Device Lot Number: 801711D
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018; 05/24/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/02/2018
• 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