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

Catalog Number EJ-05400-E

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer returned one snaplock adapter, one flat filter, and one epidural catheter.The returned components were visually examined with and without magnification.The snaplock adapter appears typical with no defects or anomalies observed.The flat filter appears typical with no defects or anomalies observed.Microscopic examination of the returned catheter indicated the catheter appears used as there is biological material between the inner coils and there is adhesive material on the outer extrusion body.No other defects or anomalies were observed.Functional testing was performed on the returned components per mrq-000017 rev.5 section 6.5 - leakage.Was inserted into the retuned.The catheter was confirmed to be secured to the snaplock adapter by tugging gently on the catheter.The components were left to sit for 72 hours in the closed position for the spo test.After 72 hours, the snaplock adapter was examined and was found in the fully closed position and the catheter remained secure in the snaplock adapter.A device history record review was not required as a part of this complaint investigation.Other remarks: no corrective action needed at this time since no functional issues were found with the returned sample.The reported complaint of the snaplock adapter was disconnected from the catheter could not be confirmed through functional testing of the returned sample.The snaplock adapter was secured to the epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.There was no problem found with the returned sample.

Event Description

The customer alleges that the catheter came off the snaplock adaptor on the second day after insertion.A new catheter was inserted.

• Brand Name: ARROW 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5438027
• MDR Text Key: 38228296
• Report Number: 3006425876-2016-00053
• 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: Other
• Type of Report: Initial
• Report Date: 01/29/2015

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: EJ-05400-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1