MAUDE Adverse Event Report: INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number 381834

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that a pack of 50 insyte autoguard pnk 20ga x 1.16in had missing label information.The following was reported by the initial reporter: "unprinted packaging".

Event Description

It was reported that a pack of 50 insyte autoguard pnk 20ga x 1.16in had missing label information.The following was reported by the initial reporter: "unprinted packaging".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/28/2021.H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two photographs and fifty units which revealed that the packages were lacking printed product information.The issue was confirmed.Preventative maintenance logs were reviewed, which verified all printing equipment and vision detection systems were up to date and functioning properly.The missing print most likely occurred as a result of human error during the manual inspection process.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12038038
• MDR Text Key: 260726074
• Report Number: 1710034-2021-00517
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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: 11/30/2023
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 0342877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1