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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. ARROW SPINAL ANES/EPIDURAL CATH KIT
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ARROW INTL., INC. ARROW SPINAL ANES/EPIDURAL CATH KIT Back to Search Results
Catalog Number AK-05560
Device Problem Material Separation (1562)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 04/17/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the flex tip plus catheter broke while being removed from the patient.The complaint states that 1 cm of the catheter remained in the patient.Neurosurgery was unable to remove the 1 cm piece of catheter at the time of the incident.
 
Manufacturer Narrative
The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
ARROW SPINAL ANES/EPIDURAL CATH KIT
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
Manufacturer Contact
margie burton, rn, reg affairs
po box 12600
durham, NC 27709
9194334965
MDR Report Key3868413
MDR Text Key15123242
Report Number1036844-2014-00199
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 04/18/2014
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-05560
Device Lot Number23F14B0206
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/18/2014
Initial Date FDA Received05/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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