MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381137
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
On (b)(6) 2025, the patient exhibited elevated blood pressure.During invasive blood pressure catheterization, the steel needle was not withdrawn prior to the procedure, resulting in a lateral crack in the catheter after insertion.The puncture site and invasive catheter were replaced, and the procedure was repeated.Re-puncture.
Additional Manufacturer Narrative
Investigation results: in addition to the fact that no records were found that could explain this complaint during the analysis of the batch history, nonconformities, and corrective maintenance, this complaint does not include samples or photos for analysis, making it impossible to confirm.According to the complaint description: ¿during venous catheterization for blood pressure measurement, the steel needle was not removed before the procedure, resulting in a lateral crack in the catheter after insertion.¿ based on the investigation carried out so far, a possible cause of the complaint may be related to: product usability: as described in the complaint, the deviation occurred during use.The catheter may have been pushed forward, and during recannulation, trans fixation of the catheter may have occurred.Product assembly: there may have been an isolated failure in the vision system, allowing a trans fixated catheter to pass to the customer.However, if the catheter had been trans fixated before puncture, its use would not have been possible.
Event or Problem Description
No additional information.

• Brand Name: ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23517017
• Report Number: 1710034-2025-01747
• Device Sequence Number: 9732925
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373(11)241220(17)291130(10)4327478
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 381137
• Device Lot Number: 4327478
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown