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

Catalog Number ASK-03000-CHU-S1

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2019

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 when they opened the product, the blue tray breaks at the same time.

Event Description

It was reported that when they opened the product, the blue tray breaks at the same time.

Manufacturer Narrative

Qn#(b)(4).The customer reported the outer tray breaks when opening the kit.The customer returned one opened kit.Visual examination of the returned kit revealed the lower right corner of the outer tray is cracked under the flange.The customer also provided a photo that shows a kit with a crack under the flange of the outer tray.No other defects or anomalies were observed.A device history record review was performed on the outer tray and kit with no relevant findings.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 breaking was confirmed based on the sample received.Visual inspection of the returned kit revealed the lower right 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 breaking when opening could not be determined.

• Brand Name: EPIDURAL CATHETERIZATION SETS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8592726
• MDR Text Key: 144556742
• Report Number: 1036844-2019-00630
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K884552
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: ASK-03000-CHU-S1
• Device Lot Number: 13F19A0521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1