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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE ACCESS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - SINGAPORE ACCESS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8419
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received and is currently awaiting evaluation. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the vented solution set deflated when the bag was compressed. The bag was not holding its seal. This occurred before use. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
(b)(4). The reported broken seal involved sterile fluid path packaging, not sterile packaging. Therefore, the original reported issue should not have been reported as the fluid path remains sterile regardless of the condition of the packaging. The device was returned for evaluation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. A visual inspection of the returned used sample found that the packaging was sealed. The packaging of the device employs breathable material which is why the customer found that it deflated upon compression. Although the packaging allows for air to enter and exit the package, the fluid path of the set remains sterile as the end caps on the set are the components that maintain the sterile barrier. The reported condition was not verified. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameACCESS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore 02573
SN 02573
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore 02573
SN 02573
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5346798
MDR Text Key35176688
Report Number1416980-2016-00343
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2020
Device Catalogue Number2C8419
Device Lot NumberSR15C18017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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