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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT; EPIDURAL KIT
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ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT; EPIDURAL KIT Back to Search Results
Catalog Number AK-05501
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2013
Event Type  malfunction  
Event Description
The complaint was reported as: the customer alleged that the catheter placement was successful with no issues.An estimated 12 hours later the pt noticed leaking from the epidural catheter.A crack was noted by the clinician.The clinician put a filter on the device and no other issues occurred.No report of a delay in treatment or a pt injury.The patient's condition is reported as fine.
 
Manufacturer Narrative
The device sample was not returned for eval at the time of this report.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION KIT
Type of Device
EPIDURAL 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, ra clinical speci
po box 12600
durham, NC 27709
9194334965
MDR Report Key3788792
MDR Text Key4363537
Report Number1036844-2014-00006
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 Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAK-05501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/03/2014
Initial Date FDA Received01/21/2014
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
Type of Device Usage Initial
Patient Sequence Number1
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