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

Catalog Number ASK-05500-KM

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2019

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 tray was found damaged before use, when the kit was taken out of the shelf in an operation room.Therefore, a new kit was used instead.

Event Description

It was reported that the tray was found damaged before use, when the kit was taken out of the shelf in an operation room.Therefore, a new kit was used instead.

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 was found broken before use.The customer returned one sealed.Visual examination of the returned kit revealed the lower left corner of the outer tray is cracked under the flange.The customer also provided photos that show a kit with a crack under the flange of the outer tray.No other defects or anomalies were observed.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 of the outer tray being damaged was confirmed based on the sample received.Visual inspection of the returned kit revealed the lower left corner had a crack under the flange.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 having a break could not be determined.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9193593
• MDR Text Key: 166997928
• Report Number: 3006425876-2019-00813
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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: ASK-05500-KM
• Device Lot Number: 71F19D1529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1