MAUDE Adverse Event Report: BECTON DICKINSON BD 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	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd insyte-w winged pnk 20ga x 1.88in catheter broke off report by medical device safety officer: according to the report, the arterial cannula has "torn off".A remnant of the arterial cannula remained in the patient's arm and had to be surgically removed by vascular surgeons.I have attached the photos i have.The patient was transferred via the emergency room or the operating room to the intensive care clinic ((b)(6)) on ward 1b.At this point, he had already been fitted with the arterial blood pressure measurement system, which initially worked without any problems.The defect only occurred after about 1 week.Since the patient is unable to move, it can be ruled out that the incident was caused by him.The remnant of the catheter has been preserved.
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
No additional information.
Additional Manufacturer Narrative
Our quality engineer inspected the photos, and 2 samples submitted for evaluation.The reported issue of catheter broken/ separated after placement was confirmed upon inspection of the samples.Analysis of the samples showed the catheter was broken on the used sample.The broken portion of the catheter was smooth which indicates a clean cut on the catheter.The representative sample had no damages or defects.The sample was subjected to a catheter pull test and was found within specification.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were 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.Given the elastic nature of the rubber pads and that there are no sharp or hard edges on the pads, this station is unlikely to cause the observed 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 scissors, or other sharp instruments should not be used at or near the insertion site.As it is unknown how the product was used, the root cause could not be established.Current controls include a functional test in place to check for catheter to adapter pull force and an in-process visual inspection in place to check for catheter damage.

• Brand Name: BD 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: 21253746
• Report Number: 2243072-2025-00025
• Device Sequence Number: 15718127
• Product Code: FOZ
• UDI-Device Identifier: 00382903813377
• UDI-Public: (01)00382903813377(11)240308(17)290228(10)4067381
• 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): 02/20/2025

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: 4067381
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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