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

Catalog Number AK-05502

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

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 there have been around 5 kits that have shown up recently either with damage to the outer tray or the lid stock partially torn off, making product not sterile for use.

Manufacturer Narrative

(b)(4).A device history record review was performed on the outer tray and kit with no relevant findings.The customer reported the outer tray of the kit was damaged.The customer returned damaged kit.Visual examination of the returned kit revealed the lower left and right corners of the outer tray are stressed and the lower left corner was cracked under the flange.No other defects or anomalies were observed.The customer also provided photos that show the corner of kit having a crack.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Per the manufacturing site, all incoming outer trays are visually inspected for evidence of stress marks prior to packaging as well as each packaged kit is inspected after sealing and prior to being placed into the corrugate container.The reported complaint that a tray was cracked was confirmed based on the sample received.Visual inspection of the returned kit revealed the lower left and right corner showed signs of stress and the left corner had a crack under the flange.The customer also provided photos that show the corner of kit having a crack.A device history record review was performed on the outer tray and kit with no relevant findings.Also, the outer trays are 100% inspected prior to and after packaging.It is unknown how the kit was handled during shipping or prior to use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the tray's corners being stressed , and cracking could not be determined.

Event Description

It was reported that there have been around 5 kits that have shown up recently either with damage to the outer tray or the lid stock partially torn off, making product not sterile for use.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9702068
• MDR Text Key: 179284363
• Report Number: 1036844-2020-00072
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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 Expiration Date: 02/28/2021
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19J0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1