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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20125046. Medical device expiration date: na. Device manufacture date: 2020-11-24. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that ll vlv adpt(stand alone) had incorrect label information. This occurred on 1301 occasions. The following information was provided by the initial reporter: material no: 2000e batch no: 20125046, 20115046, unknown. It was reported that vendor boxes are labeled for lot 20125046 on brown carton and white inner pack carton while the component connector is printed with lot 20115046. Verbatim: "nonconformance report description: mixed lots in vendor packages vendor boxes are labeled for lot 20125046 on brown carton (100 each/bx) and white inner pack carton (50 each/bx) while the component connector is printed with lot 20115046. Assembly team found multiple boxes that contained lot 20115046 exclusively and a few vendor cartons mixed with both lots, 20115046 and 20125046. All material at the assembly line had to be re-sorted during work order production, 4000 each total. Qa confirmed no incoming goods receipts for lots 20115046. Warehouse team adjusted sap lot 20115046 to the work order and used material 'as-is' with qa approval, there is no non-conformance with the item itself. Nonconforming photos: sqe confirmed mixed lots from qa photos and raw material inventory remaining original vendor packaging. 5 other 2000e raw lots in warehouse inventory examined for same labeling issue, all passed for carton lot label containing correct component lot: 20116996, 20115596, 20125683, 21016238, 21025049. 3 cartons of 100each lot 20115046 found in raw material warehouse. Nc qty. Updated to 1300 each total, stock qty. Adjusted to use ¿as-is¿. Total quantity lot 20115046 believed to be 1300 each. All 1300 each adjusted lot number in sap and used ¿as-is¿, there is no material on hold. Po records show 4400 each delivered for lot 20125046: 3 boxes nok from raw inventory containing component lot 20115046 with box label lot 20125046 have handwritten number on outside: 400, 412, 413, photos below. 4th box ok contains lot 20125046, handwritten number 369. Please review available photos of packing materials and labeling for root cause investigation. " our production line pre-clearance sequence successfully detected the mixed lots before use in kits, however all material had been deboxed with original packaging discarded. Our production team incurred >1 hour downtime resorting and separating the 4000 each into lot 20115046 and lot 20125046 for mai work order 282955. After our initial discovery of 1000 each mixed in production, we found another 300 each of raw inventory still in original bd packaging for documentation. There is no nonconformance with the item itself, all material adjustments have been completed and the material approved for use ¿as-is¿ by mai qa, there is no material on hold. 5 other raw inventory lots of item 2000e examined for the same labeling issue, no further nonconformances discovered, lots 20116996, 20115596, 20125683, 21016238, and 21025049 ok.
 
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Brand NameLL VLV ADPT(STAND ALONE)
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 Key11680474
MDR Text Key265999029
Report Number9616066-2021-50744
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
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 05/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2000E
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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