MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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.
Event or Problem Description
It was reported that during the cannulation procedure, the device failed when it broke in half, preventing it from functioning properly.As a result, it had to be discarded and replaced, requiring the patient to be reprocessed.Batch: 5116410 ref: 381244 it is noted that the emergency department has previously reported dissatisfaction with this product.The report was received on january 29.Additional information received on 12 feb 2026 quantities affected: one (1) unit of the 18g peripheral iv catheter (cs10-72700302), lot 5116410, is confirmed as affected.Evidence (photo/video): a photographic record of the device packaging is attached.There is no image of the device in use.Damage to patient health: there was no damage to the patient's health.The event was identified during the procedure and the device was replaced to continue care.Availability of sample for analysis: the sample is not available because the device came into contact with the patient and was discarded in accordance with institutional biosafety protocols.However, the product packaging is retained and provided as evidence of the event.Information for collection and replacement: since the device was discarded due to contact with the patient, it is not possible to collect the sample.If the packaging needs to be collected, please confirm so that we can provide the relevant logistics information.Is the sample contaminated? the device was considered contaminated material due to contact with the patient, which is why it was discarded according to protocol.The packaging is not contaminated.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot 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; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24433219
• Report Number: 2243072-2026-00120
• Device Sequence Number: 16050495
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: (01)00382903812448
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 381244
• Device Lot Number: 5116410
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown