MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305786
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/06/2020
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 foreign matter was found before use with a syr 10ml ll w/ndl eclipse 22x1-1/2 rb.The following information was provided by the initial reporter, "water drop in the barrel." 3 occurrences were reported.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided final lot number 9126569 and all applicable sub-assembly lot numbers.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this issue, three physical samples and one picture sample were provided for evaluation by our quality engineer team.Through examination of the samples, a material was detected on the barrel.Fourier-transform infrared spectroscopy analysis was performed on the detected material and it was determined that the material consisted of silicone.The silicone resulted from the lubrication process performed within the manufacturing facility.It has been determined that the silicone presence is within specifications.At this time, further action has not been determined necessary.
Event or Problem Description
It was reported that foreign matter was found before use with a syr 10ml ll w/ndl eclipse 22x1-1/2 rb.The following information was provided by the initial reporter, "water drop in the barrel." 3 occurrences were reported.

• Brand Name: SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB
• 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 ; MX
• MDR Report Key: 9630886
• Report Number: 9610847-2020-00014
• Device Sequence Number: 14036108
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: 30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K982541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 03/31/2024
• Device Model Number: 305786
• Device Catalogue Number: 305786
• Device Lot Number: 9126569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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