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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT
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ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05502-MGH
Device Problems Occlusion Within Device (1423); Failure to Infuse (2340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2014
Event Type  malfunction  
Event Description
The customer reports the details as: an epidural catheter was placed for obstetrician (ob) anesthesia.Once in place, the anesthesiologist could not inject the medication.The catheter was removed and found to be obstructed at the tip.No report of a patient injury or harm.
 
Manufacturer Narrative
Qn#(b)(4).The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key4652893
MDR Text Key5684247
Report Number1036844-2015-00094
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASK-05502-MGH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2015
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
Type of Device Usage Initial
Patient Sequence Number1
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