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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 14F X 28CM SPLIT STREAM; SPLIT STREAM HEMODIALYSIS CATHETER
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MEDCOMP 14F X 28CM SPLIT STREAM; SPLIT STREAM HEMODIALYSIS CATHETER Back to Search Results
Model Number SST28-J
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2019
Event Type  malfunction  
Manufacturer Narrative
One 14f split stream was returned with the arterial luer and sleeve separated from the catheter.Visual inspection shows the end of the extension line where the luer was attached is stretched.Device will be forwarded to the device contract manufacturer for investigation/evaluation.
 
Event Description
Before the start of the treatment, while flushing the catheter, the blood flow in the a-side catheter was aspirated and injected, air bubbles and leaks were observed between the silicone sleeve and the luer of the extension tube, so that the catheter was removed.
 
Manufacturer Narrative
One 14f split stream was returned with the arterial luer and sleeve separated from the catheter.Visual inspection shows the end of the extension line where the luer was attached is stretched, but not the full length of the luer barb.The facility noted that when the device was accessed air bubbles and leaks were noted, and the catheter was removed.When the device was disinfected by the distributor the luer separated from the extension tubing.The most likely cause for this incident is that the luer was not fully seated in the extension tubing during manufacturing and this condition was missed during inspection due to the sleeve covering the luer barbs.Even though this is considered an isolated incident (no other reports of this nature have been received for this device family), medcomp has issued a corrective action request to the supplier.
 
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Brand Name
14F X 28CM SPLIT STREAM
Type of Device
SPLIT STREAM HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key8595612
MDR Text Key144971886
Report Number2518902-2019-00033
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00884908084344
UDI-Public884908084344
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSST28-J
Device Catalogue NumberSST28-J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/12/2019
Initial Date FDA Received05/09/2019
Supplement Dates Manufacturer Received04/12/2019
Supplement Dates FDA Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight56
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