MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in catheter broke / separated after it was reported by customer that the catheter was broken.During the withdrawal of the catheter, part of the device remained in the patient¿s artery.Verbatim: rcc received a complaint via email.We bought the catheter iv insyte (pink) 20g x 1.88" radiopaque ¿ 381237 from medline canada.Today, (b)(6) 2025, an incident occurred in the recovery room regarding an insyte 20g bd 381237 catheter that had been inserted into the operating room earlier in the day.During the withdrawal of the catheter, part of the device remained in the patient¿s artery.According to the nurse, the site was intact and the parameters were normal before the removal.Nothing indicated a potential problem.At the time of withdrawal, there was no resistance.The nurse noticed that the catheter already appeared to be partially "out" when she simply peeled off the dressing.Significant bleeding was immediately noted.Consequences for the patient: additional bleeding occurred, as it was an artery and the nurse did not immediately notice that the catheter was broken.Fortunately, no other complications were observed, as the broken fragment could be quickly removed.We have preserved the two fragments of the catheter.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and sample submitted for evaluation.The reported issues of catheter broke/ separated after placement and leakage were confirmed upon inspection of the sample.Analysis of the sample showed a broken catheter with a smooth edge, which indicated a clean cut on the catheter.Only the broken catheter portion assembled with the adapter was returned.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The assembly process was reviewed, and the only station that is in contact with the catheter tubing is the rubber pads at the flaring station.There are no sharp or hard edges on the pads, so this station is unlikely to cause the clean cut on the catheter tubing.A simulation was carried out by using scissors to cut on the tubing.It was observed that the cut off portion area has a similar smooth edge as the complaint sample.Therefore, the broken catheter was concluded to be cut by an unknown sharp object and the defect happened outside of the manufacturing facility.According to the instructions for use (ifu) for insyte, it indicates not to use scissors or other sharp instruments at or near the insertion site.

• Brand Name: INSYTE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23717298
• Report Number: 2243072-2025-01443
• Device Sequence Number: 21432922
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370(11)241002(17)290930(10)4268493
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 381237
• Device Lot Number: 4268493
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown