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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE - AIBONITO ACCESS; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C8931
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that a clear-link access set had a bent manifold.According to the report, the reporter stated that a ¿3 port continuo-flo set had a bent manifold, which rendered the set not usable¿.The event occurred during set up of the device and before patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ACCESS
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE - AIBONITO
rd 721 km 0 3 po box 1389
aibonito PR 705
Manufacturer (Section G)
BAXTER HEALTHCARE - AIBONITO
rd 721 km 0 3 po box 1389
aibonito PR 705
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4417782
MDR Text Key5164538
Report Number1416980-2015-01902
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K932512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/29/2019
Device Catalogue Number2C8931
Device Lot NumberUR14D29062
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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