MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381247
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During arterial catheter insertion, there was no blood return.Upon withdrawing the soft catheter, approximately 2 cm was found broken and retained in the body.The likely cause was the patient¿s agitation and forceful twisting during the procedure, which led to catheter breakage.
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
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue catheter broke/ separated during use was not confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: INSYTE
• 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: 24305934
• Report Number: 2243072-2026-00092
• Device Sequence Number: 17471633
• Product Code: FOZ
• UDI-Device Identifier: 00382903812479
• UDI-Public: (01)00382903812479(10)5173518
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381247
• Device Lot Number: 5173518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 05/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/02/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown