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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI PLEXITRON SOLUTION ADMINISTRATION SETS

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BAXTER HEALTHCARE - CALI PLEXITRON SOLUTION ADMINISTRATION SETS Back to Search Results
Catalog Number MRC0001MP
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The initially reported event occurred during the unspecified date of (b)(6) 2019. (b)(6). The device was received for evaluation. A visual inspection was performed which noted that the over pouch was deliberately opened as excessive manipulation was evidenced. Therefore, the reported condition of ¿peel pouch was opened¿ was not verified. However, the visual inspection revealed that the set did not have the blue tip protector that covers the spike (20 drops). Further evaluation revealed this molded piece had incomplete filling caused in the injection molding process. The issue of defective spike connector was verified. The product did not meet specification. The cause of the damage spike connector was due to the machine molding step during the manufacturing process. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a plexitron solution administration set (sterile fluid path) had an opened peel pouch. This was identified prior to patient use. There was no patient involvement. No additional information is available.
 
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Brand NamePLEXITRON SOLUTION ADMINISTRATION SETS
Type of DevicePLEXITRON SOLUTION ADMINISTRATION SETS
Manufacturer (Section D)
BAXTER HEALTHCARE - CALI
cali
Manufacturer (Section G)
BAXTER HEALTHCARE - CALI
calle 36 no. 2c-22
apartado aero 2446
cali
CO
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8784675
MDR Text Key150846270
Report Number1416980-2019-03734
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 07/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMRC0001MP
Device Lot NumberSE18EH9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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