MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381112
Medical Device Problem Codes	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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
It was reported that bd the following information was provided by the initial reporter: it was reported that when puncturing a blood vessel, the needle got stuck inside the blood vessel and could not be advanced.When the needle was removed to check, the tip of the catheter was slightly frayed.After that, a different placement needle was used.
Additional Manufacturer Narrative
To aid in the investigation of this issue, the affected product was received for evaluation by our quality team.Through examination of the sample, it was possible to observe that the catheter tip was damaged.A device history record review was completed for provided material number 381112 and lot number 4257579.The review did identify records of poor catheter tip performance on the tipper machines which may be related to the reported incident.It is worth noting that adjustments related to the catheter tip to improve catheter tip quality were performed by operators/preparers in the area according to procedures.These adjustments were also highlighted in the device history records.Based on the investigation results, it is probable that the observed damage resulted in the catheter pointing stage in the tipper machine.According to a corrective maintenance order, several adjustments were made in order to mitigate this defect.Corrective actions for damaged catheter tip are being addressed in a current corrective and preventive action plan.
Event or Problem Description
No additional information.

• Brand Name: ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22615716
• Report Number: 9610048-2025-00096
• Device Sequence Number: 10106331
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120(11)241022(17)290930(10)4257579
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/19/2025

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: 381112
• Device Lot Number: 4257579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown