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

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.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA 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 Key: 5498299
• MDR Text Key: 40250161
• Report Number: 2518433-2016-00012
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SJ-05501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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: N
• Patient Sequence Number: 1