MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; CATHETER, PERCUTANEOUS

Catalog Number CA-11142-A

Device Problems Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports an inconsistent latex free labelling on the lid of the stock.The lid shows both "latex free" and "contains latex" labelling.The issue was detected during incoming inspection/inventory review.

Event Description

The customer reports an inconsistent latex free labelling on the lid of the stock.The lid shows both "latex free" and "contains latex" labelling.The issue was detected during incoming inspection/inventory review.

Manufacturer Narrative

(b)(4).The customer returned a closed mac finished kit for evaluation.Visual inspection of the closed kit revealed that the lidstock on the kit stated that the contents inside "contains latex" but also a figure that states the kit does not contain latex.The timestamp on the label was 1505264.A device history record review was performed and no relevant findings were identified.The customer reported issue of "latex" and "latex-free" on the lid stock was confirmed.Visual examination of the kit revealed that the label of the kit had contradicting information about latex inside the kit.A dhr review was completed with no relevant findings.The root cause of the complaint is likely packaging related.A non-conformance is currently in process to further investigate this issue.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9082229
• MDR Text Key: 167003972
• Report Number: 3006425876-2019-00731
• Device Sequence Number: 1
• Product Code: DQY
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CA-11142-A
• Device Lot Number: 71F18J0795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1