MAUDE Adverse Event Report: MEDCOMP 14F X 28CM SPLIT STREAM

Model Number SST28-J

Device Problems Air Leak (1008); Detachment Of Device Component (1104)

Patient Problems Air Embolism (1697); Infarction, Cerebral (1771)

Event Date 11/26/2016

Event Type  Injury  

Manufacturer Narrative

The device involved in this incident was not returned for evaluation.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.During validation of this device family testing was performed to assure that the separation force of the lumen to adaptor joint meets iso standard.The report stated that the doctor "did not visually check whether it was securely connected, because he connected the catheter with the compression ring attached to the stainless steel cannula part of the extension adapter." it appears that the device may not have been properly assembled leading to the extension separating from the lumen.

Event Description

During dialysis treatment, the extension adapter on the v side detached from the catheter body and air was mixed in- resulting in air embolism, cerebral infarction.

• Brand Name: 14F X 28CM SPLIT STREAM
• Type of Device: SPLIT STREAM
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 6259680
• MDR Text Key: 65051731
• Report Number: 2518902-2016-00044
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: SST28-J
• Device Catalogue Number: SST28-J
• Device Lot Number: MCAR080
• Other Device ID Number: 884908084344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention