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

Catalog Number ASK-05401-NM

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The stylet lines up with the hub but does not go all the way.There was no patient harm.

Manufacturer Narrative

Qn#(b)(4).No lot number was provided.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 needle with no relevant findings.The customer reported the stylet does not insert correctly into the needle.The customer returned one epidural needle with stylet and guard (reference attached files pic_inp1900049911).The returned needle visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears typical.However, after functional testing, microscopic examination revealed, the top of the needle hub is not parallel to the remaining hub as well as the needle itself.No visual defects or anomalies were observed with the returned stylet ((b)(4)).Functional testing was performed on the returned sample.An attempt to insert the stylet into the needle revealed the stylet hub key will not fully seat into the needle's hub.Microscopic examination revealed the notch in the stylet hub does not line up correctly with the needle's hub (reference other remarks: (b)(4)).Therefore, it's not allowing the stylet key to fully engage with the needle.Nonconformance, 40008588, have been initiated to further investigate this complaint issue.The reported complaint of the stylet not inserting correctly in the needle was confirmed based on the sample received.Functional testing revealed the stylet key could not be fully inserted into the needle correctly due to the needle's hub not being parallel with the needle.No lot number was provided.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 needle with no evidence to indicate a manufacturing related issue.The needle is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance, 40008588, has been initiated to further investigate this issue.

Event Description

The stylet lines up with the hub but does not go all the way.There was no patient harm.

• 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.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6226904
• MDR Text Key: 64013993
• Report Number: 1036844-2017-00015
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05401-NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• 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: N
• Patient Sequence Number: 1