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

Catalog Number	305786
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: an additional relevant pma/510(k) of (b)(4) applies to the syringe portion of the device a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the syr 10ml ll w/ndl eclipse 22x1-1/2 rb experienced foreign matter contamination.The following information was provided by the initial reporter: dirty inside the empty needle.
Event or Problem Description
It was reported that the syr 10ml ll w/ndl eclipse 22x1-1/2 rb experienced foreign matter contamination.The following information was provided by the initial reporter: dirty inside the empty needle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/14/2021.H.6.Investigation: a device history record review was completed for provided final lot number 9211942 and all applicable sub-assembly lot numbers.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one opened eclipse kit was returned for evaluation by our quality engineer team.Through examination of the sample, a small brown foreign particle was found attached to the syringe barrel near the 10ml marking.At this time the particle composition could not be determined.An exact manufacturing related cause for the foreign matter could not be determined at this time.

• 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: 11017416
• Report Number: 9610847-2020-00413
• Device Sequence Number: 14350994
• Product Code: FMI
• UDI-Device Identifier: 00382903057863
• UDI-Public: 00382903057863
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 305786
• Device Lot Number: 9211942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1