MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in catheter broke / separated after placement cannula was used for arterial line , upon removing the canula it had broken 1-2mm from the hub , cannula remained in the radial artery.Arterial line insertion on first pass, no wire.Monitored throughout procedure, not used in pacu.
Additional Manufacturer Narrative
As neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.

• 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; dorcan; singapore SN3 5 JH; UK SN3 5JH
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22359955
• Report Number: 2243072-2025-00809
• Device Sequence Number: 8705722
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 381237
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown