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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC7109
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 05/27/2020
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 tubing of two (2) female luer lock adapters with control-a-flo were damaged.The damage was specified as a cut in the tubing.This was identified prior to use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: only (1) actual sample was received for evaluation.Visual inspection was performed which observed a small cut on the tubing.A functional testing was performed which revealed a leak on the affected area.The reported condition was verified.The cause of the condition was due to the set left protruded while loading it into the blister cavity which resulted in a cut by the blade machine during the packaging step of the manufacturing process.The other sample was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.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 Name
I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10169569
MDR Text Key195704331
Report Number1416980-2020-03446
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberEMC7109
Device Lot Number18E13T437
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Initial Date Manufacturer Received 05/27/2020
Initial Date FDA Received06/18/2020
Supplement Dates Manufacturer Received07/08/2020
Supplement Dates FDA Received07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NA.
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