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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE
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BAXTER HEALTHCARE - DOMINICAN REPUBLIC MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE Back to Search Results
Catalog Number 2N3350
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2019
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 a one-link microbore catheter extension set had a disconnection issue.The event was further described as the "cap" (one-link component) was not properly connected to the set tubing resulting in leakage of unspecified medication.This was noted during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Product code corrected to 2n3350 based on follow up information.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
MICRO-VOLUME EXTENSION SET
Type of Device
FILTER, INFUSION LINE
Manufacturer (Section D)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
haina, san cristobal
MDR Report Key9098997
MDR Text Key159747221
Report Number1416980-2019-05178
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
PMA/PMN Number
K113227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2N3350
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRIMARY OR SYRINGE TUBING (UNSPECIFIED); UNSPECIFIED MEDICATION
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