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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E CHINA
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
2000e china 510k: this is an international code - the model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically. The domestic similar list number is 2000e. The 510k number provided is for the domestic similar product: k960280. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 19105933. Medical device expiration date: 2022-10-25. Device manufacture date: 2019-10-09. Medical device lot #: 21045806. Medical device expiration date: 2024-04-16. Device manufacture date: 2021-04-10. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 5 bd smartsite¿ needle-free connectors each from lots 19105933 and 21045806 had hair in their packaging units, and 1 connector each from the same two lots also had flow issues during the infusion. The following information was provided by the initial reporter, translated from (b)(6) to english: "after the nurse has successfully punctured the indwelling needle for the child, he unscrewed the prn and replaced it with a needle-free infusion connector, then connected the infusion dropper, opened the regulator, the liquid did not drip, and used the syringe to pump saline and inject it with resistance. It has to wait another 5~10 minutes before it can be used it normally. " "when the nurse opened the connector package, he found that there was a hair-like thing in the inner package, and then replaced it with another one. ".
 
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Brand NameBD SMARTSITE¿ NEEDLE-FREE CONNECTOR
Type of DeviceINTRAVASCULAR 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 Key12619560
MDR Text Key276145328
Report Number9616066-2021-52206
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K960280
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 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2000E CHINA
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
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

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