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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. NEUTRACLEAR NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. NEUTRACLEAR NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number EL-NC1000
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: the customer provided lot # 21c29-tw.This does not match the catalog number provided.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported neutraclear needle-free connector has a missing end cap.The following information was provided by the initial reporter, translated from dutch: "this sometimes changes with the orange neutraclear.If the scroll piece is on the wrong side, they should touch neutraclear (risk of bacteria), making them no longer want to use it.They think this is too risky.Afraid the line will get infected.".
 
Manufacturer Narrative
H6: investigation summary five el-nc1000 samples from lot 21c29-tw were received in sealed packaging for investigation.A visual inspection confirmed that the neutraclear samples were packaged in a random orientation within the packaging.The details of this feedback were forwarded to the legal manufacturer of the product, cair lgl, for investigation.They confirmed that there is no specific orientation upon which the neutraclear is placed within the packaging, the packaging of the product allows the entire product to be exposed upon opening and therefore there is no risk of contamination.A review of the production records from lot 21c29-tw did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the el-nc1000 product over the past 12 months.H3 other text : see h10.
 
Event Description
It was reported neutraclear needle-free connector has a missing end cap.The following information was provided by the initial reporter, translated from dutch: "this sometimes changes with the orange neutraclear.If the scroll piece is on the wrong side, they should touch neutraclear (risk of bacteria), making them no longer want to use it.They think this is too risky.Afraid the line will get infected.".
 
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Brand Name
NEUTRACLEAR NEEDLE-FREE CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12619449
MDR Text Key276144916
Report Number9616066-2021-52205
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2021
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
Device Operator Other
Device Catalogue NumberEL-NC1000
Device Lot Number21C29-TW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2021
Initial Date FDA Received10/12/2021
Supplement Dates Manufacturer Received11/09/2021
Supplement Dates FDA Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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