MAUDE Adverse Event Report: BD INSYTE¿ VIALON E IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 388412

Device Problem Material Deformation (2976)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insyte¿ vialon e iv catheter tip was damaged.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer reported that the catheter tip was damaged.".

Event Description

It was reported that the bd insyte¿ vialon e iv catheter tip was damaged.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported that the catheter tip was damaged.".

Manufacturer Narrative

H.6.Investigation: four photos and one sample with open packaging was received by our quality team for evaluation.From the photo, a slanted cut / tear near the catheter tip was observed.The sample was subjected to visual inspection to check for catheter damage.A long, slanted cut was observed near the catheter tip.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The assembly process was reviewed, and there is no station that will cause the observed long, slanted cut.This slanted cut on the catheter could occur during product application when the product was manipulated.As the sample was returned in the open package, the actual root cause could not be established.H3 other text : see h.10.

• Brand Name: BD INSYTE¿ VIALON E IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12254998
• MDR Text Key: 264467900
• Report Number: 8041187-2021-00663
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388412
• Device Lot Number: 0081805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2020
• 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