MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in leaked.It was reported by the customer that at the time of removal, there was no resistance.The nurse noticed that the catheter already seemed partially "out" when she simply lifted the dressing.Significant bleeding occurred immediately.Consequences for the patient: additional bleeding occurred, since it was an artery and the nurse did not immediately realize that the catheter was broken.Fortunately, no other complications were observed, as the broken fragment could be removed quickly verbatim: today, (b)(6) 2025, an incident occurred in the recovery room involving an insyte 20g bd 381237 catheter that had been inserted in the operating room earlier in the day.During the removal of the catheter, a part of the device remained in the patient's artery.According to the nurse, the site was intact and the vital signs were normal before removal.There was nothing to indicate a potential problem.At the time of removal, there was no resistance.The nurse noticed that the catheter already seemed partially "out" when she simply lifted the dressing.Significant bleeding occurred immediately.Consequences for the patient: additional bleeding occurred, since it was an artery and the nurse did not immediately realize that the catheter was broken.Fortunately, no other complications were observed, as the broken fragment could be removed quickly.We kept both fragments of the catheter.The suspected batch numbers are: ¿ batch 4361332 ¿ batch 4268493 the operating room team has set these two boxes aside and will use boxes from other batches pending your analysis.
Additional Manufacturer Narrative
This mdr was created in error based on a duplicate complaint record having been opened.

• Brand Name: INSYTE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23696237
• Report Number: 2243072-2025-01434
• Device Sequence Number: 10375863
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 381237
• Device Lot Number: UNKNOWN
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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