CENTURIAN SORBAVIEW SHIELD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-11 for CENTURIAN SORBAVIEW SHIELD * manufactured by Tri-state Hospital Supply Corp (centurian Medical).

Event Text Entries

[16548568] For the last seven months, there have been 27 events involving dislodgement of picc lines with the sorbaview securement dressing. The dislodgement was often noticed prior to or during other care. Dressings in these events were in place for differing periods of time (e. G. : 1, 2, 4, 6, and 7 days). The proper dressing technique: cross the flap and keep the hub of the catheter/line under the sorbaview. A house-wide re-education effort with the manufacturer's rep was completed. Even with the correct dressing application, lines are found out while the dressing remains intact. Troubleshooting has included:1. Additional adhesive added to dressing change kits. 2. Contact with manufacturer's rep to provide additional education to nursing staff. 3. No scissors used during dressing change. Reports of this type of event include descriptions of the dressing remaining intact, but the line was falling out or completely out. Some events have noted that iv lines were attached to the iv access point. Others had no lines attached (e. G. : capped triple lumen catheter and picc line). Examples of patient activity during this event type include: 1. Lying still in bed. 2. Turning in bed. 3. Staff transferring patient from or bed to unit bed. 4. Ambulating in room. 5. Standing for xray. 6. Scratching his neck. 7. Showering. Patient outcomes have included:1. Another central line insertion. 2. Peripheral line insertion. 3. Line remained out. 4. Io (intra-osseous) line placement. Some effects on the patient include:1. Delay in receiving pain medication. 2. Fluid infiltration. 3. Bleeding from iv access point. 4. Delay in testing (procedures requiring dye injection). 5. Difficulty accessing intravascular space during code. Site locations include:1. Antecubital. 2. Forearm. 3. Internal jugular. 4. Anterior chest.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2973648
MDR Report Key2973648
Date Received2013-02-11
Date of Report2013-02-11
Date of Event2012-07-01
Report Date2013-02-11
Date Reported to FDA2013-02-11
Date Reported to Mfgr2013-02-22
Date Added to Maude2013-02-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCENTURIAN SORBAVIEW SHIELD
Generic NameDRESSING, WOUND
Product CodeMGP
Date Received2013-02-11
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerTRI-STATE HOSPITAL SUPPLY CORP (CENTURIAN MEDICAL)
Manufacturer Address301 CATRELL DRIVE HOWELL MI 48843 US 48843

Device Sequence Number: 2

Brand NameCENTURIAN SORBAVIEW SHIELD
Generic NameDRESSING, WOUND
Product CodeMGP
Date Received2013-02-11
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age*
Device Sequence No2
Device Event Key0
ManufacturerTRI-STATE HOSPITAL SUPPLY CORP (CENTURIAN MEDICAL)
Manufacturer Address301 CATRELL DRIVE HOWELL MI 48843 US 48843


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-11

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