MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921030235
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by customer.
Event or Problem Description
The user facility reported to the stryker sales representative that the tourniquet began to leak during a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.

• 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 Key: 7988047
• Report Number: 0001811755-2018-01756
• Device Sequence Number: 16250258
• Product Code: KCY
• UDI-Device Identifier: 37613154599432
• UDI-Public: 37613154599432
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 10/20/2018

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: 5921030235
• Device Lot Number: 60095185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1