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

Catalog Number EC-05500

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a user found that the catheter came off the snap lock adaptor at a patients ward. According to the hospital, any tension was unlikely to be applied by the patient since he/she was not in the condition of being able to change position by him/herself. As a result of this issue, the catheter was removed and replaced by a new one.

Manufacturer Narrative

(b)(4). A device history record review could not be performed as no lot number was provided by the customer. A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. The device history records were not reviewed as no lot number was provided by the customer. Therefore, the potential cause of the catheter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a sample.

Event Description

It was reported that a user found that the catheter came off the snap lock adaptor at a patients ward. According to the hospital, any tension was unlikely to be applied by the patient since he/she was not in the condition of being able to change position by him/herself. As a result of this issue, the catheter was removed and replaced by a new one.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7370111
• MDR Text Key: 103527476
• Report Number: 3006425876-2018-00174
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: EC-05500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage