MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 3-L CVC KIT: 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDC-42703-1A

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

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports receiving central line kit that is mislabeled.

Event Description

The customer reports receiving central line kit that is mislabeled.

Manufacturer Narrative

(b)(4).The sample was not returned; however, the customer provided two photos for evaluation.Evaluation of the photos reveals the banner card insert shows the correct part number (cdc-42703-1a) and catheter length (16cm); however, the lidstock information card displays the incorrect part number (cdc-45703-1a and catheter length (20cm).This would indicate that the incorrect lidstock information card was used during the packaging of these kits.A device history record review was performed on the manufacturing of this product and no relevant manufacturing issues were identified.The customer reported issue of the incorrect part number and catheter length being listed on the lidstock label was confirmed through evaluation of the provided photos.Evaluation of the photos revealed that the lidstock information label listed the part number as cdc-45703-1a instead of the correct number cdc-42703-1a and the catheter length as 20cm instead of the correct length 16cm.The information label is attached during packaging of the kit; therefore, the probable root cause of this issue is packaging related.A capa is currently in-process further investigate this issue.

• Brand Name: ARROW 3-L CVC KIT: 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9040018
• MDR Text Key: 177675649
• Report Number: 9680794-2019-00348
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CDC-42703-1A
• Device Lot Number: 13F18L0759
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1