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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - AIBONITO ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8399
Device Problem Reflux within Device (1522)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A peritoneal dialysis patient experienced blood backflow due to improper connections with a one-link device. The event was further described as "the blood back flowed into the one link and clogged the connector". It was not reported if the hospitalization was prolonged. A new picc line was inserted which is "uncomfortable for the patient and also causes a delay in getting the patient's their medication". The amount of time for the delay in the patient receiving their medications and fluids was not reported. The patient outcome was not reported. No additional information is available.
 
Manufacturer Narrative
A batch review was conducted on lot numbers ur16d03016 and ur16c17034 (reported by the customer as ¿potentially associated lot numbers¿). There were no deviations found related to this reported condition during the manufacture of these lots. The device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Functional and simulated use testing were performed with satisfactory results. The device passed the clear passage and pressure test. The reported condition was not verified. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameONE-LINK NEUTRAL LUER ACTIVATED DEVICE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - AIBONITO
aibonito
Manufacturer (Section G)
BAXTER HEALTHCARE - AIBONITO
rd 721 km 0 3 po box 1389
ni
aibonito 00705
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5943722
MDR Text Key54475195
Report Number1416980-2016-15126
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7N8399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/12/2016 Patient Sequence Number: 1
Treatment
0.22 MIRON FILTER; NON-BAXTER 3-WAY STOP COCK; NON-BAXTER ARGYL PICC; NON-BAXTER EXTENSION SET; NON-BAXTER PRIMARY SET; UNSPECIFIED EXTENSION SET
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