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

Catalog Number ASK-05001-SLR1

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

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

Per medwatch: it is reported that when the spinal needle was opened it was cracked on the luer lock end.There was no patient injury.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needles with no relevant findings.The customer reported the luer end of the epidural needle was cracked.The customer returned one epidural needle and lidstock.The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed that the needle appears typical.Microscopic examination of the needle's hub revealed damaged at the luer end.There appears to be tooling marks as well as a crack.The cannula and cannula's tip does not appear to be used.No other defects or anomalies were observed.Nonconformance have been initiated to further investigate this complaint issue.The reported complaint of the luer end of the epidural needle being damaged was confirmed based on the sample received.Visual examination of the returned needle revealed damage of the hub at the luer end that appears to be tooling marks.The cannula and tip did not appear to be used.A device history record review performed on the epidural needle showed no evidence to suggest a manufacturing other remarks: related cause.The epidural 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

Per medwatch: it is reported that when the spinal needle was opened it was cracked on the luer lock end.There was no patient injury.

• 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: 6918356
• MDR Text Key: 89393934
• Report Number: 1036844-2017-00363
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: 23F17A0404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• 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