MAUDE Adverse Event Report: BECTON DICKINSON INSYTE-W WINGED PNK 20GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381337
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
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
The catheter was inserted into the radial artery preoperatively for monitoring purposes only.At the end of the procedure, the catheter was pulled out.The staff member performing the procedure noticed that the catheter was shorter than usual.It was then determined sonographically that a large part of the catheter was still in the artery.An attempt was made to remove it using forceps.However, as this was unsuccessful, the remaining part of the catheter had to be surgically removed from the artery.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of catheter separated/ broke after placement was confirmed upon inspection of the sample.Analysis of the sample showed a broken catheter with a smooth edge.This indicated a clean cut on the catheter.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.Given the elastic nature of the rubber pads, there are no sharp or hard edges on the pads.This station is unlikely the cause of the clean cut on the catheter.A simulation was carried out by using scissors to cut the tubing.It was observed that the cut 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.

• Brand Name: INSYTE-W WINGED PNK 20GA X 1.88IN
• 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: 23291277
• Report Number: 2243072-2025-01248
• Device Sequence Number: 4824235
• Product Code: FOZ
• UDI-Device Identifier: 00382903813377
• UDI-Public: (01)00382903813377
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381337
• Device Lot Number: UNKNOWN
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown