MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 12X3.5, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921212235
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a procedure, the customer attempted to inflate the cuff, the cuff did fill up, but did not stay full.The possible harm associated with this event is blood loss and if this type of malfunction were to reoccur during a bier block procedure, it could pose the risk of systemic exposure to local anesthetic.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
The customer reported that during a procedure, the customer attempted to inflate the cuff, the cuff did fill up, but did not stay full.The possible harm associated with this event is blood loss and if this type of malfunction were to reoccur during a bier block procedure, it could pose the risk of systemic exposure to local anesthetic.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.

• Brand Name: DISP. 12X3.5, 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: 8508810
• Report Number: 0001811755-2019-01172
• Device Sequence Number: 1767577
• Product Code: KCY
• UDI-Device Identifier: 37613154599715
• UDI-Public: 37613154599715
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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): 05/30/2019

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: 5921212235
• Device Lot Number: 60110649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1