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

Catalog Number	381211
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n yel 24ga x 0.56in catheter defective / damaged.Date of occurrence: (b)(6) 2024.Incident description: during a vvp insertion on a 4-month-old baby, we opened the catheter packaging and removed the catheter from its case.It was defective (broken piece of plastic), preventing vvp insertion.This is not the first time this has happened to us.Happened.Sometimes it happens when we've pricked the baby.The plastic tip deflects, weakening the vein until it ruptures.Rupture.This forces us to prick the child several times.Patient information: patient's current condition: catheter change, we took another catheter having noticed the damage before pricking, but this is not the case.But this is not always the case.Actions taken in the care facility to manage the patient: catheter changed, we took another another catheter having noticed the damage before pricking, but this is not always the case.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.Current control there is in-process inspection in place to check for catheter tip damage.There is also functional test in place to check for catheter tip penetration force.No photo/sample was received for further investigation.Root cause could not be determined.
Event or Problem Description
Date of occurrence: on (b)(6) 2024 incident description: during a vvp insertion on a 4-month-old baby, we opened the catheter packaging and removed the catheter from its case.It was defective (broken piece of plastic), preventing vvp insertion.This is not the first time this has happened to us.Happened.Sometimes it happens when we've pricked the baby.The plastic tip deflects, weakening the vein until it ruptures.Rupture.This forces us to prick the child several times.Patient information: patient's current condition: catheter change, we took another catheter having noticed the damage before pricking, but this is not the case.But this is not always the case.Actions taken in the care facility to manage the patient: catheter changed, we took another another catheter having noticed the damage before pricking, but this is not always the case.

• Brand Name: BD INSYTE-N YEL 24GA X 0.56IN
• Common Device Name: 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21060045
• Report Number: 2243072-2024-01278
• Device Sequence Number: 8154132
• Product Code: FOZ
• UDI-Device Identifier: 00382903812110
• UDI-Public: (01)00382903812110(11)221129(17)271130(10)2330043
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381211
• Device Lot Number: 2330043
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown