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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8399
Device Problem Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported an underinfusion occurred during use of a one-link needle-free iv connector.During 0.9% sodium chloride (nacl) infusion via free flow, the user attracted a non-baxter 50ml syringe for an iv push of doxurubicine.This interrupted the gravity flow the primary infusion.Which caused the expected infusion time of ten minutes to infuse over 15 minutes instead.Additionally, the patient¿s peripherally inserted central catheter (picc) was attached with a clearlink system continu-flo solution set.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h6 and h10.H10: 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
ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - AIBONITO
rd 721 km 0 3 po box 1389
aibonito 00705
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12627427
MDR Text Key276353459
Report Number1416980-2021-06248
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/10/2021
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 Health Professional
Device Catalogue Number7N8399
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/17/2021
Initial Date FDA Received10/13/2021
Supplement Dates Manufacturer Received10/24/2021
Supplement Dates FDA Received11/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
0.9% SODIUM CHLORIDE; ARISURE CML; BD SYRINGE 50ML; CLEARLINK CONTINU-FLO SOLUTION SET; DOXURUBICINE; PICC LINE
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