MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921034135
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when the tourniquet cuff was placed on the patient during a procedure, the seam split open and would not inflate.
Event or Problem Description
The user facility reported that when the tourniquet cuff was placed on the patient during a procedure, the seam split open and would not inflate.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7919282
• Report Number: 0001811755-2018-01687
• Device Sequence Number: 11125256
• Product Code: KCY
• UDI-Device Identifier: 37613154599456
• UDI-Public: 37613154599456
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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 Number: 5921034135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1