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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ACUVANCE PLUS SAFETY IV CATHETER REF #3355.

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SMITHS MEDICAL ACUVANCE PLUS SAFETY IV CATHETER REF #3355. Back to Search Results
Model Number ACUVANCE PLUS SAFETY IV CATHETER
Device Problem Detachment Of Device Component (1104)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/26/2016
Event Type  Injury  
Event Description
Acuvance plus safety iv catheter 18g 32mm ref #3355 lot unk but most likely due to stock inventory (b)(4). Iv was placed in preop area for surgery on (b)(6) 2016. Nothing unusual about the iv start noted by the rn only one attempt performed and successful. Iv placed on medial aspect of forearm just above wrist. Was properly secured and anchored. Bleeding was noted from iv site early am on (b)(6) 2016 site examined by nurse tape loosened and hub secured to tape without evidence of catheter. The catheter could be palpated in the soft tissue. X-ray confirmed location of the catheter retained in patient. Physician removed iv catheter after performing a cutdown type procedure. X-ray confirmed fb no longer present after procedure.
 
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Brand NameACUVANCE PLUS SAFETY IV CATHETER REF #3355.
Type of DeviceIV CATHETER
Manufacturer (Section D)
SMITHS MEDICAL
MDR Report Key6063661
MDR Text Key58756485
Report NumberMW5065674
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACUVANCE PLUS SAFETY IV CATHETER
Device Catalogue Number3355
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/26/2016 Patient Sequence Number: 1
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