MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd insyte yel 24ga x 0.75in.
Event or Problem Description
It was reported that bd insyte yel 24ga x 0.75in catheter broke / separated before placement 9-week-old infant treated for feeding problems and respiratory deterioration.During catheter insertion, the catheter broke twice at the top during an attempt to perfuse the patient.Clinical consequences : catheter not inserted with doctor's consent.No other consequences for the patient.
Event or Problem Description
9-week-old infant treated for feeding problems and respiratory deterioration.During catheter insertion, the catheter broke twice at the top during an attempt to perfuse the patient.Clinical consequences : catheter not inserted with doctor's consent.No other consequences for the patient.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production run.The returned sample passed the visual inspection with no catheter tip damage observed.The sample also passed the catheter tip penetration test within the specifications.As current control, there is in-process visual inspection in place to check for catheter tip damage.There is also catheter tip penetration functional test in place to check for catheter tip force, which is able to detect the catheter tip defect.As the returned sample passed in visual inspection and functional test, hence actual root cause could not be established.

• Brand Name: BD INSYTE YEL 24GA X 0.75IN
• 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: 20656003
• Report Number: 2243072-2024-01117
• Device Sequence Number: 4400098
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: (01)00382903812127(11)230428(17)280430(10)3111497
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 381212
• Device Lot Number: 3111497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown