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

Catalog Number EJ-05400-E

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleged event: the snaplock adaptor could not connect with the catheter.As a result, a new kit was used, the first catheter was removed and a new one was inserted.There was no harm to the patient.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter and snaplock adapter with no relevant findings.The customer returned one epidural catheter and one snaplock adapter for investigation, reference file pic_inp1900043908.The returned components were visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears typical with no observed defects or anomalies.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical.No defects or anomalies were observed.An attempt to insert the returned catheter into the returned snaplock adapter was made.The catheter will not thread past the opening in the snaplock adapter cap.A second attempt was made using the returned catheter with a lab inventory snaplock adapter.The catheter would insert into the lab inventory snaplock adapter with no difficulty indicating that there are no functional issues found with the returned catheter.Other remarks: specifications per graphic k-05520-004b rev.02 were reviewed as a part of this complaint investigation.The reported complaint of inability to insert the catheter into the snaplock adapter was confirmed based upon the sample received.The inner diameter of the cap for the snaplock assembly was found to be out of specification as a result of excessive adhesive residue circumvolving the inner rim of the cap.Therefore, the potential cause of this complaint issue is manufacturing related.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.

Event Description

Alleged event: the snaplock adaptor could not connect with the catheter.As a result, a new kit was used, the first catheter was removed and a new one was inserted.There was no harm to the patient.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION SET
• 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: 5497760
• MDR Text Key: 40240396
• Report Number: 3006425876-2016-00060
• 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: company representative,foreig
• 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

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: EJ-05400-E
• Device Lot Number: 71F15B0615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• 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