MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-N VIALON-E 24GA X 0.56IN; INTRAVASCULAR CATHETER

Catalog Number 388411

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte-n vialon-e 24ga x 0.56in catheter was defective / damaged the following information was provided by the initial reporter; the catheter wiggles and flaps during use.

Manufacturer Narrative

If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production of the affected batch.As current controls, there are outgoing and hourly in-process visual inspections in place to check for catheter damage.No photo/sample was received for further investigation.Root cause could not be determined.

Event Description

The catheter wiggles and flaps during use.

• Brand Name: BD INSYTE-N VIALON-E 24GA X 0.56IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18315213
• MDR Text Key: 330332565
• Report Number: 2243072-2023-02166
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903884117
• UDI-Public: (01)00382903884117
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388411
• Device Lot Number: 2176905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2022
• 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