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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 3000 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE - ENGLEWOOD 3000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938741
Device Problems Cap (424); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the infusion port cap of an exactamix 3000 ml eva tpn bag was ¿bent and split¿. This was noted by the patient prior to use. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection of the photograph revealed the spike port cap broken off. The reported condition was verified. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand Name3000 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - ENGLEWOOD
englewood CO
Manufacturer (Section G)
BAXTER HEALTHCARE - ENGLEWOOD
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7795351
MDR Text Key117586967
Report Number1416980-2018-05212
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberH938741
Device LOT NumberASKU
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 Received08/22/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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