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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X50CM DUAL VASCU-PICC
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MEDICAL COMPONENTS, INC. 2.6F X50CM DUAL VASCU-PICC Back to Search Results
Model Number MR17012600
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 06/16/2019
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated.Additional information has been requested.When the investigation is complete a final report will be submitted.
 
Event Description
Il rn paged to room, upon arrival found picc disconnected @ il catheter + picc drsg in place, il s/a blood.Drsg d/c'd + pressure applied @ insertion site + called for assistance.
 
Manufacturer Narrative
No device was returned for evaluation and no photographs were provided.Clarification of description and additional information was requested but not provided.Without clarification it is not possible to determine what the issue was.
 
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Brand Name
2.6F X50CM DUAL VASCU-PICC
Type of Device
VASCU-PICC
Manufacturer (Section D)
MEDICAL COMPONENTS, INC.
1499 delp drive
harleysville PA 19438
MDR Report Key9438349
MDR Text Key200840225
Report Number2518902-2019-00075
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00884908093711
UDI-Public884908093711
Combination Product (y/n)N
PMA/PMN Number
K102966
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/14/2020
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 Date02/14/2022
Device Model NumberMR17012600
Device Catalogue NumberMR17012600
Device Lot NumberMLNC240
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/15/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received11/15/2019
Supplement Dates FDA Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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