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

Catalog Number	381137
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd angiocath catheter cracked and leaked.The following information was provided by the initial reporter: on (b)(6) 2025, the patient was given a puncture arterial tube placement and found to have blood oozing from the puncture, and was given frequent dressing changes after which blood oozing still existed, and was then found to be oozing out of the indwelling needle hose, which was removed and found to have a crack in the tubing, and the catheter was immediately replaced, and invasive bp was continuously monitored in the radial artery on the other side.The incident was reported to the equipment department.
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.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381137 and lot number 2087291.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 22332196
• Report Number: 9610048-2025-00086
• Device Sequence Number: 20939831
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373(11)220429(17)270331(10)2087291
• 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,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 2087291
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown