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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC
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STRYKER INSTRUMENTS-KALAMAZOO DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC Back to Search Results
Catalog Number 5921030235
Medical Device Problem Code Decrease in Pressure (1490)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/06/2018
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported to the stryker sales representative that during a procedure the device would not keep pressure and air leaked out.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported to the stryker sales representative that during a procedure the device would not keep pressure and air leaked out.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT
Common Device Name
TOURNIQUET, PNEUMATIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7962412
Report Number0001811755-2018-01741
Device Sequence Number1644880
Product Code KCY
UDI-Device Identifier37613154599432
UDI-Public37613154599432
Combination Product (Y/N)N
Initial Reporter CountryFI
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 11/21/2018
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
Operator of Device No Information
Device Catalogue Number5921030235
Device Lot Number60088052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Initial Date Received by Manufacturer 09/18/2018
Supplement Date Received by Manufacturer09/18/2018
Initial Report FDA Received Date10/12/2018
Supplement Report FDA Received Date11/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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