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

Catalog Number	381137
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient is a long-term inpatient undergoing continuous invasive blood pressure monitoring.On (b)(6) 2026, the arterial catheter was replaced.Overnight, blood seepage was observed at the puncture site.The nurse tightened the connector, applied gauze pressure to the puncture site, and changed the dressing.During the morning shift handover, the nurse observed continued bleeding at the arterial puncture site on the patient's left hand.Upon re-examination, a ruptured soft-tip catheter was identified as the source of leakage.The arterial line was repositioned and reinserted.Failure to detect this issue promptly could have resulted in persistent bleeding.
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
Investigation results: during the analysis of this complaint, the batch history, nonconformance records, and corrective maintenance logs were reviewed, and no records and/or evidence were found that could be linked to this occurrence.Furthermore, since the complaint was not received by a sample or photos for analysis, it was not possible to confirm the reported defect.Based on the investigation results so far, no root cause has been identified for this complaint.
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 ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24458219
• Report Number: 9610048-2026-00025
• Device Sequence Number: 10148297
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373(11)250509(17)300331(10)5086187
• 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): 03/20/2026

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: 381137
• Device Lot Number: 5086187
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown