MAUDE Adverse Event Report: ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT; EPIDURAL KIT

Catalog Number EC-05520-P

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that one day after placement of the catheter; the catheter was found separated around 30 cm from the proximal end of the catheter.The alleged incident occurred on a (b)(6) patient.The complaint states that there was some movement (turn over in his sleep) while the catheter was placed in his body.The catheter was removed and there was no need for further treatment.No report of a patient injury.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• 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 clinic splst ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3879962
• MDR Text Key: 16540612
• Report Number: 1036844-2014-00042
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EC-05520-P
• Device Lot Number: RF3026932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR