MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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.
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in catheter broke / separated after placement it was reported by the customer that when the catheter was removed, part of the device remained in the patient's artery.According to the nurse, the site was intact, and the parameters were normal before the removal.Verbatim: rcc received a complaint via email.Date: (b)(6) 2025 as per client, when the catheter was removed, part of the device remained in the patient's artery.According to the nurse, the site was intact and the parameters were normal before the removal.There was no indication of a potential problem.
Additional Manufacturer Narrative
This mdr was created in error based on a duplicate complaint record having been opened.

• 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: 23768636
• Report Number: 2243072-2025-01466
• Device Sequence Number: 10631768
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370(11)241002(17)290930(10)4268493
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 381237
• Device Lot Number: 4268493
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown