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

Catalog Number	306500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 before use of the 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe, "one of the flushes in one of the boxes was tinted in color.It was brown and it had particles coming off of the stopper.It had what appeared to be a clump of rust on the stopper." there was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Lot number 806011d for product code (b)(4) was provided for evaluation by our quality engineer for the reported defect of foreign matter.A device history record review did not reveal any documented quality issues during the production of the provided lot number that could have contributed to the reported defect.As no physical samples or picture samples were provided, 120 retained samples of the same lot number were obtained from the manufacturing facility for further investigation.The retained samples were 100% visually inspected and no foreign matter was observed.As the actual sample was unavailable and a lab analysis could not be performed for the reported foreign matter, a definite cause could not be determined for this incident.The root cause of the reported foreign matter could not be determined as no sample or photo was provided.A lab analysis of the foreign matter could not be performed as no sample was provided.Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.
Event or Problem Description
It was reported that before use of the 10 ml bd pre-filled normal saline syringe, in 10 ml syringe, "one of the flushes in one of the boxes was tinted in color.It was brown and it had particles coming off of the stopper.It had what appeared to be a clump of rust on the stopper." there was no report of exposure, serious injury or medical intervention.

• Brand Name: 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRI
• Common Device Name: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7790600
• Report Number: 2134319-2018-00108
• Device Sequence Number: 19199673
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: 02/28/2021
• Device Catalogue Number: 306500
• Device Lot Number: 806011D
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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