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

Catalog Number ASK-05001-SLR1

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2017

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

The injection needle in the epidural kit appears to have had external pressure pressed upon the distal tip and it is distorted.There was no patient involvement.

Manufacturer Narrative

(b)(4).A device history record review was performed on the injection needles with no relevant findings.The customer reported the injection needle appears to be bent at the tip.The customer returned one 18ga injection needle and lidstock.The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears typical.Microscopic examination of the needle bevel revealed the needle tip is bent outward (b)(4).The reported complaint of the injection needle tip being bent was confirmed based on the sample received.Visual examination of the returned injection needle revealed the tip of the needle bevel was bent.A device history record review was performed on the injection needles with no evidence to indicate a manufacturing related issue.The 18ga injection needle is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance has been initiated to further investigate this issue.

Event Description

The injection needle in the epidural kit appears to have had external pressure pressed upon the distal tip and it is distorted.There was no patient involvement.

• 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: 6638140
• MDR Text Key: 77517379
• Report Number: 1036844-2017-00243
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: ASK-05001-SLR1
• Device Lot Number: 23F17C0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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