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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 2N3342
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing of a non-dehp three lead extension set had a hole which caused a leak.It was further reported that the hole was located between the upper two branches of tubing and the lower branch, in a portion of the tubing with no slide clamp.The issue was identified during use on a baby in the nicu (neonatal intensive care unit).It was reported that the patient was already on unspecified antibiotics at the time of the event.The set was in use to deliver total parental nutrition (tpn) to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information : the device was received for evaluation.A visual inspection was performed using the naked eye which observed that all components are correctly placed and according to product specifications, however, a pin hole was observed in the tubing.Due to the nature of the returned sample no functional testing was performed.The reported problem was verified.The cause of the condition was not determined.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
MICRO-VOLUME EXTENSION SET
Type of Device
FILTER, INFUSION LINE
Manufacturer (Section D)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
haina, san cristobal
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina, san cristobal 91000
DR   91000
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9162099
MDR Text Key161782069
Report Number1416980-2019-05448
Device Sequence Number1
Product Code FPB
UDI-Device Identifier00085412004778
UDI-Public(01)00085412004778
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K113227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/08/2019
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 Number2N3342
Device Lot NumberDR18G18064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/10/2019
Initial Date FDA Received10/07/2019
Supplement Dates Manufacturer Received10/24/2019
Supplement Dates FDA Received11/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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