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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA STOPCOCK STOPCOCK, I.V. SET

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BAXTER HEALTHCARE - MALTA STOPCOCK STOPCOCK, I.V. SET Back to Search Results
Catalog Number ZMC7401
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This occurred on an unknown date in (b)(6) 2016. (b)(6). The device was received for evaluation. Visual inspection revealed that the paper of the pouch was damaged. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The reported condition was verified. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the sterile packaging was damaged on a stopcock in blister pack. This occurred before use. There was no patient involvement. No additional information is available.
 
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Brand NameSTOPCOCK
Type of DeviceSTOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE - MALTA
marsa
Manufacturer (Section G)
BAXTER HEALTHCARE - MALTA
a47 industrial estate
marsa
MT
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6234314
MDR Text Key64217910
Report Number1416980-2016-19145
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue NumberZMC7401
Device Lot Number16D30V143
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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