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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ATLACOMULCO SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - ATLACOMULCO SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number ABC2707
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 02/07/2019
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 there was a break in the sterile packaging of an access solution set. The break in the sterile packaging was identified prior to patient use. There was no patient involvement. No additional information available.
 
Manufacturer Narrative
The device was received for evaluation. Visual inspection using the naked eye revealed that the primary package was broken. No functional testing was performed as the reported condition was verified during initial inspection. The cause of the condition could not be determined. Twelve (12) retention samples were visually inspected at the plant with no issues noted. The reported condition was not verified on the retention samples. 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.
 
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Brand NameSOLUTION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - ATLACOMULCO
atlacomulco
MDR Report Key8396102
MDR Text Key138114175
Report Number1416980-2019-01222
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberABC2707
Device Lot Number50ZJE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

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