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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT: 19GA; ANESTHESIA CONDUCTION KIT
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ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT: 19GA; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AK-05501
Device Problems Break (1069); Material Separation (1562)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 08/13/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that after surgery, the epidural catheter was noted to be torn apart near the snaplock connection.Another catheter was inserted.
 
Manufacturer Narrative
Additional info was requested from the user facility.To date, the mfr has not received additional info from the user facility.The device sample was not returned for eval at the time of this report.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION KIT: 19GA
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTL., INC.
reading PA 19605
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key4094994
MDR Text Key4841277
Report Number1036844-2014-00350
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 Other Health Care Professional
Type of Report Initial
Report Date 08/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAK-05501
Device Lot Number23F14D0972
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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