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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 EXT SET W/ VLV PORT & LL; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXT SET W/ VLV PORT & LL; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 30207E
Device Problem Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2022
Event Type  malfunction  
Event Description
It was reported while using bd ext set w/ vlv port & ll the device was difficult to disconnect.There was no report of patient impact.The following information was provided by the initial reporter: received another complaint from our wards re not being able to disconnect the lines from the cannula.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-oct-2022.Investigation summary: one 30207e sample was received without packaging for investigation; the lot number of the complaint sample was reported unknown, residual fluid was present in the device.The returned sample was received with the female luer connected to the male luer of an unknown connecting product which had been cut.The feedback provided by the customer indicates difficulty was experienced when attempting to disconnect the smartsite extension set from the connecting lines.As part of the investigation the customer provided a photograph of the complaint sample; analysis of the photograph, in addition to a visual inspection of the returned sample did not identify any defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting the returned sample to various products from bd stock and attempting to flush with fluid; no connection issues or flow issues were detected from the male or female luer, and the components could be easily disconnected in each instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned sample did not identify any product defects that could have contributed to the customer¿s experience.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.
 
Event Description
It was reported while using bd ext set w/ vlv port & ll the device was difficult to disconnect.There was no report of patient impact.The following information was provided by the initial reporter: received another complaint from our wards re not being able to disconnect the lines from the cannula.
 
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Brand Name
BD EXT SET W/ VLV PORT & LL
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15789729
MDR Text Key307811045
Report Number9616066-2022-01712
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203011495
UDI-Public07613203011495
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number30207E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2022
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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