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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD MEDICAL STATLOCK PICC PLUS FOAM CATHETER STABILIZATION DEVICE

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BARD MEDICAL STATLOCK PICC PLUS FOAM CATHETER STABILIZATION DEVICE Back to Search Results
Catalog Number VPPCSP
Event Date 12/15/2011
Event Type  Malfunction  
Event Description

Hard plastic clip portion of statlock device came separated from the adhesive foam portion of the device. The patient required a dressing change when this occurred. The placement of the picc line was fortunately not affected and another statlock device was utilized during the dressing change. Anecdotally, the nurse assisting with the dressing change noted that at the prior dressing change, the statlock device in use at that time had also had the hard plastic clip portion separated from the adhesive foam backing. No lot number information available for the prior device. ======================manufacturer response for catheter stabilization device, statlock picc plus foam (per site reporter)======================included in prior report dated 09/11.

 
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Brand NameSTATLOCK PICC PLUS FOAM
Type of DeviceCATHETER STABILIZATION DEVICE
Manufacturer (Section D)
BARD MEDICAL
289 bay rd.
queensbury NY 12804
MDR Report Key2407771
Report Number2407771
Device Sequence Number1
Product CodeKMK
Report Source User Facility
Type of Report Initial
Report Date 12/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device EXPIRATION Date03/31/2014
Device Catalogue NumberVPPCSP
Device LOT NumberJUVCF581
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/29/2011
Device Age3 dy
Event Location Hospital

Patient TREATMENT DATA
Date Received: 12/29/2011 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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