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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CBCII(NO DRN)PKG/6 W/CAPACITOR; APPARATUS, AUTOTRANSFUSION
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STRYKER INSTRUMENTS-KALAMAZOO CBCII(NO DRN)PKG/6 W/CAPACITOR; APPARATUS, AUTOTRANSFUSION Back to Search Results
Catalog Number 0225028000E
Device Problem Suction Problem (2170)
Patient Problem Hematoma (1884)
Event Date 06/22/2014
Event Type  Injury  
Event Description
It was reported that during installation of the cbc ii, after a procedure for removal of a hematoma, the suction system failed.As a result, a greater hematoma was formed.It was reported that, "clinical consequences observed: recurrent subdural hematoma under bandage." the procedure was completed successfully utilizing a standard suction drain.No medical intervention was reported with this event.
 
Event Description
It was reported that during installation of the cbc ii, after a procedure for removal of a hematoma, the suction system failed.As a result, a greater hematoma was formed.It was reported that, "clinical consequences observed: recurrent subdural hematoma under bandage." the procedure was completed successfully utilizing a standard suction drain.No medical intervention was reported with this event.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
Manufacturer Narrative
The ¿y¿ connector and drain tube were not returned.No blood residues were observed inside the reservoir or tubing system.No defect, damage or malfunction was detected in the returned unit; therefore, the claimed condition could not be confirmed.The device was discarded by the manufacturer.
 
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Brand Name
CBCII(NO DRN)PKG/6 W/CAPACITOR
Type of Device
APPARATUS, AUTOTRANSFUSION
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3972951
MDR Text Key4608656
Report Number0001811755-2014-02752
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K952224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0225028000E
Device Lot Number13341012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/19/2014
Initial Date FDA Received08/01/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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