MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 8"; CATHETER INTRAVASCULAR THERAPE

Catalog Number CA-24301

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reported the packaging was damaged.The device was not used on the patient.

Manufacturer Narrative

(b)(4).The customer returned one , unopened cvc kit for analysis.No definite-signs-of-use were observed.Visual analysis revealed a sterility breach on the bottom-right corner of the outer tray.White stress marks were also observed around three of the four corners of the tray including at the location of the crack.No defects or anomalies were observed with the seal.A device history record review was performed, and no relevant findings were identified.The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-right corner of the tray was cracked.Stress marks were also observed on three of the four corners , including at the location of the crack.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample received, design caused or contributed to this event.A capa was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported the packaging was damaged.The device was not used on the patient.

• Brand Name: ARROW CVC KIT: 16 GA X 8"
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11177182
• MDR Text Key: 227027316
• Report Number: 9680794-2021-00031
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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: CA-24301
• Device Lot Number: 13F19H0373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1