MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
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 propofol was drawn up into the bd luer-lok syringe with detachable needle and two brown areas of discoloration were observed inside the barrel.
Additional Manufacturer Narrative
Correction and updated to: it was reported that propofol was drawn up into the bd luer-lok¿ syringe with bd eclipse¿ safety needle and two brown areas of discoloration were observed inside the barrel.Updated from: it was reported that propofol was drawn up into the bd luer-lok syringe with detachable needle and two brown areas of discoloration were observed inside the barrel.Correction and updated to: bd luer-lok¿ syringe with bd eclipse¿ safety needle.Updated from: bd luer-lok syringe with detachable needle.Investigation summary: no samples were received of 10ml eclipse product 305786 with lot number unknown.No samples or pictures were sent to show the defect that customer found.According to issue stated by customer the defect is ¿brown discoloration was noticed in the syringe after drawing up medication.¿ review of dhr was performed and no issues stated by the customer were found.According to the statement of complaint we cannot confirm the issue stated by the customer and we cannot assign it as a manufacturing defect, we will inform to the production personnel about this issue so they can be aware of it.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Based on the investigation we were not able to determine the root cause due that we could not reproduce the issue and we do not have a lot number as reference, we were not able to confirm the issue.Root cause: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Based on the investigation we were not able to determine the root cause due that we could not reproduce the issue and we do not have a lot number as reference, we were not able to confirm the issue.Rationale: based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.
Event or Problem Description
It was reported that propofol was drawn up into the bd luer-lok¿ syringe with bd eclipse¿ safety needle and two brown areas of discoloration were observed inside the barrel.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7123586
• Report Number: 9610847-2017-00197
• Device Sequence Number: 19188320
• Product Code: FMI
• UDI-Device Identifier: 00382903057863
• UDI-Public: 00382903057863
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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 Catalogue Number: 305786
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/02/2018
• 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