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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 4 IN MINIBORE SET W/ T-CONNECTOR & INJ INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 4 IN MINIBORE SET W/ T-CONNECTOR & INJ INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number ME1046
Device Problems Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20087364. Medical device expiration date: 2025-08-28. Device manufacture date: 2020-08-28. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. 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 1 4 in minibore set w/ t-connector & inj set from lot 20087364, 1 set from an unspecified lot were difficult to disconnect from the iv tubing. The following information was provided by the initial reporter: we are back to the old t-tubes again on the pixs. #870254. These were the ones that we had problems getting them disconnected from the iv tubing and we got our old ones back and we did not have problems. Uses a bd t-connector extension set me1046 in our nicu, and we have been having a real struggle with the product not disconnecting easily from iv tubing.
 
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Brand Name4 IN MINIBORE SET W/ T-CONNECTOR & INJ
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 Key11646034
MDR Text Key265619522
Report Number9616066-2021-50683
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberME1046
Device Catalogue NumberME1046
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
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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