MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number AK-05560

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the epidural needle is bending when used on larger patients.

Event Description

It was reported that the epidural needle is bending when used on larger patients.

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.A corrective action is not required at this time as the potential cause of the needle bending could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.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 suggest a manufacturing related cause.Therefore, the potential cause of the needle bending could not be determined based upon the information provided and without a sample.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8179657
• MDR Text Key: 130916885
• Report Number: 1036844-2018-00321
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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: Health Professional
• Device Catalogue Number: AK-05560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1