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

Catalog Number TI-05501-ME

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.However, the customer did provide photos that clearly show an epidural needle that looks to be damaged at the tip and a bent cannula.A device history record review could not be performed as no lot number was provided by the customer.Therefore, a review of sales history data could not be performed to obtain a lot number.A corrective action is not required at this time.Based on the provided photos indicate operational context caused or contributed to this event.Complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of the needle was damaged during use was confirmed based on a photos provided from the customer.Visual examination of the customer provided photos revealed an epidural needle that was damaged at the tip and had a bent cannula.Therefore, based on the photo provided, operational context caused or contributed to this event.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the epidural kit from arrow brand 19g was used for a patient when the physician was unable to pass the catheter.When he removed the needle he found the tip shattered.The patient's condition is unknown at this time.

Event Description

It was reported that the epidural kit from arrow brand 19g was used for a patient when the physician was unable to pass the catheter.When he removed the needle he found the tip shattered.The patient's condition is unknown at this time.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no lot number was provided by the customer.Therefore, a review of sales history data could not be performed to obtain a lot number.Visual inspection could not be performed as no sample was returned by the customer for investigation.However, the customer did provide photos that clearly show an epidural needle that looks to be damaged at the tip and a bent cannula.Complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of the needle was damaged during use was confirmed based on a photos provided from the customer.Visual examination of the customer provided photos revealed an epidural needle that was damaged at the tip and had a bent cannula.The device history records were not reviewed as no lot number was provided by the customer and therefore, no sales history records could be found from this customer for this product.Therefore, based on the photo provided, operational context caused or contributed to this event.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7288739
• MDR Text Key: 100927106
• Report Number: 3006425876-2018-00138
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TI-05501-ME
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1