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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number SJ-05501
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has been returned for investigation but the report has not been submitted at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
Alleged event: anesthesia connected catheter to patient. Nurse came and checked in on patient and noticed the catheter has separated. Catheter was replaced. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). No lot number was provided by the customer. A device history record review was performed based upon a lot number from sales history data. A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. The customer returned one epidural catheter and one epidural catheter piece for investigation reference files (b)(4). The returned catheter and catheter piece were visually examined with and without magnification. Visual examination of the returned catheter revealed that the catheter appears used. Adhesive residue is present on the catheter body exterior and the catheter body is kinked at several locations. The catheter is not separated. Both the proximal and distal tips were confirmed to be present. Visual examination of the returned catheter piece revealed that the piece is from the catheter's proximal end. The point of separation indicates that the catheter has been cut. The coils remain tightly wound with no stretching visible in the extrusion or inner coils. The rest of the catheter was not returned. No other defects or anomalies were observed. The returned catheter was measured using a other remarks: calibrated ruler ((b)(4)). The returned catheter measures approximately 91. 4 cm which is within specification of 88. 5-91. 5 cm per graphic kz-05400-002 rev. 08. The catheter was returned in its entirety. The returned catheter piece measures approximately 4. 4 cm. At least 84. 1 cm of the second catheter was not returned. Specifications per graphic kz-05400-002 rev. 08 were reviewed as a part of this complaint investigation. The ifu for this product, e-17019-100c rev. 01, was reviewed as a part of this complaint investigation. The ifu for this product warns the user "do not alter the catheter or any other kit/set component during insertion, use, or removal. " the point of separation on the catheter piece indicates that the catheter has been cut. No signs of stretching were present in the coils or extrusion. A corrective action is not required at this time as the condition of the sample received indicates that user error caused or contributed to this event. The reported complaint of a catheter separation was confirmed based upon the sample received. The returned catheter piece was confirmed to be the separated proximal end of the epidural catheter. The damage observed at the point of separation indicates that the catheter has been cut. The ifu for this product instructs the user, "do not alter the catheter or any other kit/set component during insertion , use, or removal. " a device history record review was performed based upon a lot number from sales history data. A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, based upon the damage at the point of separation, use error caused or contributed to this event.
 
Event Description
Alleged event: anesthesia connected catheter to patient. Nurse came and checked in on patient and noticed the catheter has separated. Catheter was replaced. The patient's condition was reported as fine.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
2400 bernville road
reading PA 19605
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5498299
MDR Text Key40250161
Report Number2518433-2016-00012
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSJ-05501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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