MAUDE Adverse Event Report: TELEFLEX MEDICAL VCLUDE TI LG 24/CART 15/BOX; CLIP, IMPLANTABLE

Catalog Number 60415

Device Problem Expiration Date Error (2528)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that this item has been sent to the customer, but the incorrect expiration is on the label.The customer stated she received 10 boxes of item, 60415, with the incorrect expiration dates on them.I checked the batch and the stock number, and the system is showing the expiration date is 02/01/2021.The customer sent attachments showing the expiration date is 02/01/2020.I believe there is a labeling issue.

Manufacturer Narrative

Qn#(b)(4).The finished goods dhr was reviewed.Per the dhr, lot number 7808 of product 60415 vclude ti lg 24/cart 15/box was manufactured on 06feb2017.A total of (b)(4) units were manufactured.Dhr investigation did not show issues related to complaint.There is no evidence to suggest a manufacturing related cause.The customer returned one box 60415 vclude ti lg 24/cart 15/box for investigation.Visual examination of the returned sample revealed that the packaging labels on the box and the cartridges had expiration dates of 2020-02-01.The supplier was consulted and the expiration date of 2020-02-01 was confirmed.The reported complaint of "product has expiration date 2020-02-01" is confirmed.A nonconformance has been initiated by the global logistics & distribution team to further investigate this issue.Corrective actions are being implemented to prevent this issue from recurring.Reference file anp20034367 for investigation photos.The reported complaint of "product has expiration date 2020-02-01" was confirmed based upon the sample received.Visual examination confirmed that the packaging labels on the box and the cartridges had expiration dates of 2020-02-01.A nonconformance has been initiated by the global logistics & distribution team to further investigate this issue.Corrective actions are being implemented to prevent this issue from recurring.

Event Description

It was reported that this item has been sent to the customer, but the incorrect expiration is on the label.The customer stated she received 10 boxes of item, 60415, with the incorrect expiration dates on them.I checked the batch and the stock number, and the system is showing the expiration date is 02/01/2021.The customer sent attachments showing the expiration date is 02/01/2020.I believe there is a labeling issue.

• Brand Name: VCLUDE TI LG 24/CART 15/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9770760
• MDR Text Key: 191038130
• Report Number: 3011137372-2020-00084
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K091060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 60415
• Device Lot Number: 7808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1