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

Catalog Number	381123
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/28/2026
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 the needle pierced the catheter."it was reported that during peripheral iv cannulation with the angiocath, flashback was obtained confirming venous access.Upon partial withdrawal of the needle and advancement of the catheter into the vein, the need tip appeared distorted (see image attached), with separation at the distal needle tip." response received on: 5/7/2026 was patient or user harmed? if yes, please explain.The patients were not harmed; however, they experienced pain during iv catheter insertion and throughout the time the catheter remained in the vein.It is stated that "similar occurrences have been noticed on multiple occasions with different nurses" - have these past events been reported to bd (if so, could you reference any record numbers).If these events have not been reported, could you provide any additional details for these events? all events were reported together in a single communication, although they likely involved different nurses at different times.

• 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 ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25175332
• Report Number: 9610048-2026-00070
• Device Sequence Number: 16093804
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: (01)00382903811236(11)240417(17)290331(10)4079619
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 07/08/2026

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: 381123
• Device Lot Number: 4079619
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown