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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PERIPHERALLY INSERTED CENTRAL CATHETER; SPECTRA SAFE-CUT - SAFETY SCALPEL
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BARD ACCESS SYSTEMS PERIPHERALLY INSERTED CENTRAL CATHETER; SPECTRA SAFE-CUT - SAFETY SCALPEL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2014
Event Type  Injury  
Event Description
It was reported to the rep that the nurse experienced a scalpel cut with a spectra safe-cut safely scalpel, this occurred a few months ago and the rep has just received the info.The nurse required going to occupational hlth and has since had the all clear from testing.Date: (b)(6) 2014 - attended occupational hlth, bloods obtained from the nurse and the pt, (b)(6) vaccine administered, with booster follow up 2 months and 9 months first aid only required.
 
Manufacturer Narrative
A lot history review (lhr) review is not possible, as no mfg lot number has been provided by the complainant.The device has not been returned to the mfr for eval.
 
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Brand Name
PERIPHERALLY INSERTED CENTRAL CATHETER
Type of Device
SPECTRA SAFE-CUT - SAFETY SCALPEL
Manufacturer (Section D)
BARD ACCESS SYSTEMS
salt lake city UT
Manufacturer Contact
christy chandonia
605 north 5600 west
salt lake city, UT 84116
8015224969
MDR Report Key4332272
MDR Text Key5143481
Report Number3006260740-2014-00586
Device Sequence Number1
Product Code GDZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received11/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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