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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG PEDIATRIC ARTERIAL CANNULAE
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MAQUET CARDIOPULMOARY AG PEDIATRIC ARTERIAL CANNULAE Back to Search Results
Model Number 70102.2682
Device Problems Fracture (1260); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2011
Event Type  malfunction  
Event Description
On (b)(6) 2011 the customer stated that they noticed that the guide wire of the cannulae is too short and fractures on the tip.(b)(4).
 
Manufacturer Narrative
(b)(4).The design of the cannula was checked and improved to get a better handling in the assembling line.(b)(4).
 
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Brand Name
PEDIATRIC ARTERIAL CANNULAE
Type of Device
ARTERIAL CANNULAE
Manufacturer (Section D)
MAQUET CARDIOPULMOARY AG
kehler strasse 31
rastatt, 7643 7
GM  76437
Manufacturer (Section G)
MAQUET CARDIOPULMOARY AG
kehler strasse 31
rastatt, 7643 7
GM   76437
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4278480
MDR Text Key21721567
Report Number8010762-2014-00371
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K023251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2011
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 Model Number70102.2682
Device Catalogue Number70102.2682
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/20/2011
Event Location Hospital
Date Report to Manufacturer09/20/2011
Initial Date Manufacturer Received 09/20/2011
Initial Date FDA Received11/26/2014
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 Initial
Patient Sequence Number1
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