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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938739
Device Problems Cap (424); Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The lot was manufactured from august 08, 2019 - august 12, 2019. The device was received for evaluation. A visual inspection was performed, and it was noted that the spike port cap was detached and loose in the primary packaging which caused a leak issue. The reported issue was verified. The cause of the loosely attached spike port cap was likely due to inadequate or lack of cyclohexanone being applied to the spike port cap when it was inserted to the spike port tubing 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

During evaluation of a returned 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag, it was observed that the spike port cap was detached and loose in the primary packaging. This event was discovered during sample testing prior to patient use. There was no patient involvement. No additional information is available.

 
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Brand Name1000 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
AVAILMED
c. industrial lt. 001 mz. 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX 22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9983200
MDR Text Key188532513
Report Number1416980-2020-02296
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 04/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberH938739
Device LOT Number60199676
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/09/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
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 Unkown

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