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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 10F X 18CM SPLIT CATH XL; SPLIT CATH XL HEMODIALYSIS CATHETER

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MEDCOMP 10F X 18CM SPLIT CATH XL; SPLIT CATH XL HEMODIALYSIS CATHETER Back to Search Results
Model Number ASPC18P-XL
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 01/27/2018
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information.
 
Event Description
Accidental disconnection of arterial line.Blood loss <20cc.
 
Manufacturer Narrative
The device involved in the incident was not removed and remains implanted in the patient and in use.No evaluation of the device can be performed.The device was implanted for 8 months prior to the incident.No reports of a similar incident with this device have been received.Attempts to obtain additional information regarding the incident were unsuccessful.The female luers are manufactured to meet the iso standard (iso 594-2:1998).They are universal female luers and will mate with any universal male luer of the bloodlines, syringes, injection caps, etc.If they are also manufactured to the iso standard.Without an evaluation of the device the investigation cannot determine if the failure was related to manufacturing.It is unlikely due to the device having been in use and continues to be used with no reported problems.It is possible the connection to the blood line was not fully secured at the onset of the hemodialysis treatment.
 
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Brand Name
10F X 18CM SPLIT CATH XL
Type of Device
SPLIT CATH XL HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key7660390
MDR Text Key113299565
Report Number2518902-2018-00041
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00884908003437
UDI-Public884908003437
Combination Product (y/n)N
PMA/PMN Number
K020936
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 05/06/2019
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? No
Device Operator Other
Device Expiration Date10/30/2018
Device Model NumberASPC18P-XL
Device Catalogue NumberASPC18P-XL
Device Lot NumberMHJJ150
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/29/2018
Initial Date FDA Received07/03/2018
Supplement Dates Manufacturer Received05/29/2018
Supplement Dates FDA Received05/07/2019
Patient Sequence Number1
Treatment
FRESENIUS BLOOD TUBING
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight14
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